08-Sole Source Justification - Leica HistoCore LIGHTNING S Slide Printer - Updated2.docx

Sole Source Justification - Leica HistoCore LIGHTNING S Slide Printer The Mouse Embryo Phenotyping Core requests procurement of the Leica HistoCore LIGHTNING S Slide Printer (Product Code: 149061000C1), configured per Leica Microsystems Inc. on a sole source basis from Leica Microsystems Inc./Leica Biosystems or an authorized Leica Biosystems distributor.

Leica Biosystems is the manufacturer and provider of the HistoCore LIGHTNING S slide printer platform and the associated manufacturer-supported hardware, drivers, accessories, filters, warranty, service, and technical support required for operation. The system uses HistoCore LIGHTNING S direct laser slide printing technology and is designed to support both on-demand and batch slide printing workflows in histology laboratories.

The required configuration consists of:

Product Code 149061000C1 - HistoCore LIGHTNING S; quantity 1 Product Code 14061061490 - Batch_assy; quantity 1 Product Code 14061062260 - master_filter_bs; quantity 1 Product Code 9CON-S-LGHTNGS 1-5 - Lightening S Silver Service Age 1-5 yrs; quantity 4 Product Code 14041157009 - Power cord USA - 15 AMP; quantity 1 Estimated freight and handling charges for Ground + White Glove Service

No alternative commercially available system has been identified that provides the required combination of:

Direct UV laser slide printing with high-resolution, consistent, and durable text and two-dimensional barcode output on histology slides;

Both on-demand and batch printing modes in a compact footprint suitable for integration into the Core's sectioning and slide preparation workflow;

Clear and durable printing that remains legible through heat, commonly used histology chemicals, staining, coverslipping, physical handling, imaging, and long-term archiving;

Compatibility with Leica slides and mainstream slide brands, minimizing disruption to established Core histology protocols and consumable workflows;

Manufacturer-supported drivers, instrument accessories, filtration components, maintenance, warranty, and service support from Leica Biosystems or its authorized support network.

Alternative general-purpose label printers, adhesive label systems, thermal slide printers, or inkjet systems would not provide the same combination of durable direct laser marking, barcode readability, chemical and heat resistance, batch/on-demand flexibility, and manufacturer-supported compatibility with the Core's histology workflow. Use of a non-compatible or non-equivalent system would require additional workflow validation and could introduce specimen identification variability during sectioning, staining, imaging, and archiving.

The included Silver Service coverage is required to protect the instrument and sustain validated performance. Manufacturer-supported service is necessary because the instrument must be maintained to factory specifications, use manufacturer parts, and receive support from Leica-trained engineers with authorized access to Leica service diagnostic and calibration software. Third-party service or unsupported parts would not provide equivalent assurance of performance, security, uptime, or compliance with manufacturer specifications.

Standardization on the Leica HistoCore LIGHTNING S is critical to maintain a secure link between slide identifiers and the corresponding mouse embryo samples, genotypes, developmental stages, stains, and project records. The requested platform will reduce manual transcription, support consistent barcode-enabled tracking, and preserve continuity with histology slide preparation and digital imaging workflows used by the Core and its collaborators.

Leica Microsystems Inc./Leica Biosystems or an authorized Leica Biosystems distributor is the only responsible source capable of providing the required instrument configured as the HistoCore LIGHTNING S slide printer, together with the necessary manufacturer-supported accessories, filtration components, service coverage, warranty, and technical support. Accordingly, sole source procurement is justified.