Sol_75N98026Q00941.pdf

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National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q00941

JADDUA JOHNSTON

+10

000-000000

08/04/2026

08/19/2026 1200 ED

Multiple

The purpose of this NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION is to acquire evaluation of a Lead NNMT

Inhibitor in Humanized Mouse Models of

Chronic Kidney Disease

Period of Performance: 08/31/2026 to

08/30/2027

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the contracting officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

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NSN 7540-01-152-8067

75N98026Q00941

HTTPS://ACQUISITION.GOV/FAR

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award Management

Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government Entity

Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in

Equal Employment Opportunity Investigations

(Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

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Award enclosure:

Quote

Statement of Work

IPP Invoicing and Payment Provisions

To avoid delay in payment, all invoices must be uploaded into the invoicing processing platform

(IPP) (https://www.ipp.gov). The invoice must match the line item description on the purchase order. It must also state that payment is to be made using a three-way match.

You are reminded that only the contracting officer of record can make any changes to this award any changes made at the direction of the program without an executed modification and null and void and are done at the contractor's own risk.

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: Evaluation of a Lead NNMT Inhibitor in Humanized Mouse Models of Chronic Kidney Disease

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q00941. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a contract or purchase order without providing for full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a Firm-Fixed Price on a non-competitive basis GemPharmatech LLC 11175 Flintkote AVE STE B San Diego, California 92121- 1209, United States for GemPharmatech is the only known source capable of providing the required services because it developed the humanized nicotinamide N-methyltransferase (hNNMT) mouse model under prior NIH-funded work (PO 75N95023P00824) and maintains the cryopreserved sperm and breeding resources necessary to regenerate the colony. The NCATS lead NNMT inhibitor exhibits lower activity against mouse NNMT than human NNMT; therefore, evaluation in mice expressing human NNMT is required to generate scientifically relevant efficacy data.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular August 4, 2026

(iv) The associated NAICS code is 541714 – Research and Development in Biotechnology (except Nanobiotechnology) and the small business size standard is 1,000 employees. This requirement is not set aside for small business.

(v) Description of Requirement:

NCATS requires commercially available preclinical testing services to evaluate their lead NNMT inhibitor, developed in collaboration with U Chicago, in the following two models of chronic kidney disease. 1) The high adenine diet model that causes kidney disease (KD) through a sequence of chemical precipitation, mechanical blockage, and a severe localized inflammatory response which essentially forces the kidney to self-destruct from the inside out. 2) The High-Sugar High-Fat Diet combined with Streptozotocin (HSHFD+STZ) protocol is one of the most widely used inducible models for modeling Diabetic Kidney Disease (DKD) especially Diabetic Nephropathy (DN).

However, the NNMT inhibitors developed at NCATS have lower activities against the mouse form of NNMT. Therefore, it is imperative that we do our evaluation in mouse models that contain the human form of the enzyme. An existing humanized NNMT mouse line was previously generated by GemPharmatech under Purchase Order 75N95023P00824 using CRISPR/Cas9 genome editing. The current requirement utilizes this established mouse line and does not include development of a new model.

The Contractor shall provide the following services:

SERVICE 1 – Recovery and production of 50♂ male hNNMT homozygous mice SERVICE 2 – Adenine study: Efficacy study of lead NNMTi in adenine diet induced KD SERVICE 3 – HSHFD+STZ study: Efficacy study of lead NNMTi in HSHFD+STZ induced DKD

(vi) Delivery Location: NIH/NCATS- 9808 Medical Center Drive, Rockville, MD 20850

(vii) [Reserved, if needed]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any additional instructions as required.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party.

The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award. Add additional evaluation criteria as required.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) Submission Requirements:

Responses must include sufficient information to demonstrate the respondent’s capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B. point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide:

(a) Product, catalog, model, and/or part number(s);

(b) Product description;

(c) Documentation demonstrating that the offered item meets all required salient characteristics;

(d) Quantity;

(e) Estimated price or cost;

(f) Shipping, handling, and/or installation charges; and

(g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by August 19, 12:00PM EST and must reference solicitation number 75N98026Q00941. Responses may be submitted electronically to Jaddua.Johnston@nih.gov

(xv) Point of Contact:

Jaddua Johnston Contracting Specialist, Phone Number: 240-569-0006

Email: Jaddua.Johnston@nih.gov

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Evaluate humanized NNMT mice 1) Adenine diet induced kidney disease; 2) diabetic nephropathy (kidney damage) model caused by High-Sucrose High-Fat Diet (HSHFD) and streptozotocin (STZ).

These are follow-up studies of prior PO 75N95023P00824 with GemPharmatech, LLC.

Statement of Need and Purpose:

The National Center for Advancing Translational Sciences (NCATS) requires commercially available preclinical contract research services to evaluate a lead nicotinamide N-methyltransferase (NNMT) inhibitor in two established mouse models of chronic kidney disease using GemPharmatech's existing humanized NNMT mouse line. These studies are a follow-on to Purchase Order 75N95023P00824.

The Contractor shall provide animal production services to generate the required study animals from the existing humanized NNMT colony, conduct efficacy studies in two well-established disease models, perform the specified laboratory analyses, and provide final study reports. The two studies include: (1) an adenine diet-induced chronic kidney disease model, in which kidney injury results from adenine crystal deposition, tubular obstruction, and subsequent inflammation; and (2) a high-sucrose high-fat diet combined with streptozotocin (HSHFD+STZ) model, a widely used inducible model of diabetic kidney disease/diabetic nephropathy.

Because the NCATS NNMT inhibitor demonstrates substantially lower activity against the murine NNMT enzyme than the human enzyme, evaluation in the existing humanized NNMT mouse model is required to generate pharmacology data relevant to the intended therapeutic target. The purpose of this procurement is to obtain these established preclinical testing services and the associated study data.

Background Information and Objective:

Under Purchase Order 75N95023P00824, GemPharmatech generated a humanized NNMT mouse line using CRISPR/Cas9 genome editing to replace the endogenous mouse Nnmt gene with the human NNMT gene. This model was developed to support evaluation of NNMT inhibitors that demonstrate substantially lower potency against the murine enzyme than the human enzyme in biochemical and cellular assays.

Additional animals from this established mouse line are required to conduct the requested pharmacology/efficacy studies. GemPharmatech will recover the existing colony from cryopreserved sperm using its standard colony recovery procedures and produce approximately 50 male homozygous humanized NNMT mice suitable for use in the requested studies. The Contractor will then perform two established fee-for-service efficacy studies using commercially available chronic kidney disease models:

(1) an adenine diet-induced kidney disease model and (2) a high-sucrose high-fat diet plus streptozotocin (HSHFD+STZ)-induced diabetic kidney disease model. The Contractor will perform the specified in vivo procedures, laboratory analyses, histopathology, and reporting in accordance with its standard commercial testing services.

The objective of this procurement is to obtain commercially available preclinical animal production and contract research services to evaluate the NCATS lead NNMT inhibitor in established humanized mouse models of chronic kidney disease and diabetic kidney disease, and to obtain the associated study data and final reports.

Period of Performance:

12 months with periodic updates after award

SCOPE OF WORK

General Requirements:

The Contractor shall provide commercially available preclinical contract research services, including all personnel, facilities, equipment, materials, and technical expertise necessary to perform the services described in this Statement of Work.

Specific Requirements:

The Contractor shall provide the following services:

SERVICE 1 – Recovery and production of 50♂ male hNNMT homozygous mice SERVICE 2 – Adenine study: Efficacy study of lead NNMTi in adenine diet induced KD SERVICE 3 – HSHFD+STZ study: Efficacy study of lead NNMTi in HSHFD+STZ induced DKD

SERVICE 1

Recovery of the existing humanized NNMT mouse line from cryopreserved sperm will involve a two-step process: (1) recovery of the line into live heterozygous mice via in vitro fertilization (IVF), and (2) breeding of these mice to generate approximately 50 male homozygous humanized NNMT mice for use in the studies described in this Statement of Work.

The Mouse strain: 40+8 hNNMT mice, male, shall be provided by GemPharmatech.

Service Schedule: Services will begin upon receipt of the purchase order, execution of the applicable contractual documents, and receipt of required study materials.

Deliverables and Acceptance Upon study endpoint, a final report will be provided to the Client within three (3) weeks through electronic delivery, unless otherwise specified and agreed. The Client shall review the final report from GemPharmatech and provide comments within two (2) weeks. If no comments are received within the two (2) week time period, the final report shall be deemed accepted by the Client and the Services defined in this SOW shall be considered complete.

Client Material Client Material and Reagent must be received prior to the commencement of the Service unless agreed by both Parties in writing otherwise. Any delay from the Client in delivery of the required Material or Reagent may lead to a delay in the Service. Providing less Material or Reagent than requested by GemPharmatech may result in study delays or incomplete progress. GemPharmatech will make an effort to make the best use of the Material and Reagents provided. In the event that the study is initiated, as per the Client's request, prior to Material/Reagent receipt at the testing site, and the Material/Reagent is not received on time, the Client is responsible for all study-associated costs incurred to date and any repeat study.

Materials/Reagents/Agents Standard generic agents and clinical-grade non-generic agents may be provided by either GemPharmatech or the Client. GemPharmatech reserves the right to adjust the total cost of the Services should any reagent costs (including vehicle) change during performance by amending the SOW as agreed by both Parties.

In the event of cancellation or termination requested or caused by the Client, the Client is responsible for paying GemPharmatech for all costs incurred by GemPharmatech related to the Services prior to the cancellation or termination, including the cost of all mice used.

Study will initiate within 2 weeks of receipt of all agents/reagents at GemPharmatech Co. Ltd.

LEVEL OF EFFORT:

N/A

GOVERNMENT RESPONSIBILITIES

NCATS will supply compounds, earlier PK methods, and formulation methods to CRO.

DELIVERY OR DELIVERABLES

Upon study endpoint, a final report will be provided to the Client within three (3) weeks through electronic delivery, unless otherwise specified and agreed. The Client shall review the final report from GemPharmatech and provide comments within two (2) weeks. If no comments are received within the two (2) week time period, the final report shall be deemed accepted by the Client and the Services defined in this SOW shall be considered complete.

REPORTING REQUIREMENTS

The Contractor shall provide progress reports of NNMT mice production and progress in efficacy and tolerability studies and electronic final study reports upon completion of each study.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Patnaik, Samarjit (NIH/NCATS) [E] <patnaiks@mail.nih.gov>

Information System Security Plan:

Data Rights:

All data generated under this Statement of Work shall belong to NCATS.

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Contractor will not publish any information without informing NCATS. All information is confidential and NCATS will solely determine date for publication or publicity or patenting.

Confidentiality of Information:

All information shared between NCATS and the Contractor is confidential. The timing and method of any disclosure shall be determined by NCATS.

Title