Product Scope Definition

Effective Date: March 15, 2026 | Version 1.0

Purpose and Defining Principle

This Product Scope Definition establishes the categories of products that may and may not be listed on the ExuraBio Life Science Surplus Materials Exchange. The Platform's defining scope is surplus non-consumable laboratory and biomanufacturing materials — meaning materials and equipment used in research, development, or manufacturing processes that are not dispensed to patients and are not single-use or disposable.

This scope includes bulk process materials (such as media, buffers, and raw materials), single-use bioprocessing consumables, disposable labware, durable instruments, and equipment, provided they are surplus and fall within the permitted categories defined below. All Sellers must ensure their listings fall within permitted categories and comply with applicable legal, regulatory, and safety requirements. ExuraBio reserves the right to update this policy at any time and to remove or suspend non-conforming listings.

Core Regulatory Note: ExuraBio operates as a platform facilitator for non-pharmaceutical laboratory and biomanufacturing process materials. This scope is intentionally distinct from finished drug products and prescription biologics, which are subject to DSCSA chain-of-custody requirements. The Platform's permitted scope does not include finished drug products, APIs, or any material intended for patient administration.

Permitted Product Categories

The following categories of surplus laboratory and bioprocessing materials and equipment are permitted on the Platform, subject to the conditions and documentation requirements set forth below:

Bulk Process Materials

The following categories of bulk surplus materials are permitted, provided they are sold as surplus in original or partially used bulk quantities and, where required under this Policy, are accompanied by the original Certificate of Analysis (COA) and lot documentation:

• Cell culture media — basal media, specialty media, serum-free formulations, and proprietary media formulations, in bulk or original manufacturer-sealed containers;

• Buffers and buffer salts — including PBS, HEPES, Tris, citrate, phosphate, and custom formulations — in bulk quantities;

• Excipients used in formulation development — stabilizers, surfactants, and tonicity agents used in biopharmaceutical process development (not including finished drug formulations);

• Raw materials used in biopharmaceutical manufacturing — upstream and downstream process inputs excluding active pharmaceutical ingredients (APIs) and finished drug products;

• Process chemicals and chromatography resins — buffers and solutions used in downstream processing, prepacked or loose chromatography resin lots, and bulk resin surplus;

• Reagents and biochemicals used in quality control and analytical testing — reference standards, assay reagents, and analytical-grade biochemicals used in process analytical technology (PAT) and QC testing.

Durable Labware

• Laboratory glassware intended for repeated use — bottles, flasks, vessels, graduated cylinders, beakers, and other reusable glassware not designed for single-use disposal;

• Durable plasticware — polypropylene and polycarbonate vessels, carboys, and storage containers;

• Reusable filter housings, tangential flow filtration (TFF) cassette holders, and chromatography column bodies.

Laboratory Instruments and Equipment

• Benchtop equipment: centrifuges, vortexes, heat blocks, magnetic stirrers, water baths, and hot plates;

• Refrigeration and cryogenic storage equipment — laboratory refrigerators, ultra-low temperature freezers, and liquid nitrogen storage systems.

• Biosafety cabinets and fume hoods — Sellers must include the current certification date, certification body, and last-service date in the listing.

• Incubators and environmental chambers — CO2 incubators, shaking incubators, and humidity chambers.

• Analytical instruments: UV-Vis spectrophotometers, plate readers, fluorimeters, infrared spectrometers, and refractometers.

• PCR and nucleic acid analysis instruments, thermal cyclers, real-time PCR systems, and digital PCR systems.

• Electrophoresis systems, horizontal and vertical gel rigs, power supplies, and gel tanks.

• Liquid handling instruments — electronic pipettors, multichannel pipettors, repeater dispensers, and automated liquid handlers.

• Bioreactors and fermenters: reusable stirred-tank bioreactors and fermentation vessels (hardware only; single-use bioreactor bags are excluded).

• Chromatography instruments: HPLC systems, FPLC systems, AKTA systems, and GC instruments.

• Imaging systems: gel documentation systems, fluorescence and brightfield microscopes; electron microscopes are permitted for institutional Buyer-to-institutional transactions only.

• Balance and weighing equipment, pH meters, conductivity meters, and electrochemistry instruments.

• Autoclave and sterilization equipment, vacuum pumps, and pressure equipment.

• Flow cytometers and cell sorters.

• Software licenses bundled with a listed instrument where the license is transferable under the applicable vendor license terms.

Condition Disclosure: New, used, and refurbished materials and equipment are all permitted. Sellers MUST clearly and prominently disclose product condition. For equipment: service history, calibration records (where available), and any known defects. For materials: storage condition history and any known deviations from manufacturer-specified storage must be explicitly disclosed.

Single-Use and Disposable Bioprocessing Consumables

The following single-use and disposable laboratory and bioprocessing consumables are permitted on the Platform. Because ExuraBio operates solely as a platform facilitator and does not manufacture, repackage, relabel, or take title to these products, facilitating their sale does not require ExuraBio to obtain an FDA establishment registration, a wholesale distributor license, or any other government license or approval. Regulatory compliance obligations for these products rest entirely with the Seller. All listings in this category must include a product grade declaration (Research Grade or GMP/Bioprocess Grade) and comply with ExuraBio’s Seller Verification and Listing Standards Policy.

• General disposable labware — T-flasks (T-25, T-75, T-175, T-300), PCR tubes, PCR plates, sealing films, microcentrifuge tubes, conical tubes, and similar single-use research labware. Products must be labeled for the declared intended use grade and must not be marketed for clinical diagnostic, patient management, or direct patient use applications.

• Single-use bioprocessing assemblies — single-use bioreactor bags and assemblies, hollow fiber cartridges, single-use tangential flow filtration (TFF) cassettes, mixing bags, storage bags, and associated fluid path components. GMP-grade listings must include ISO 10993 biocompatibility documentation, USP Class VI or USP <88> test results, extractables and leachables study data, and a Certificate of Analysis per manufacturing lot.

• Disposable filtration and separation products - bottle-top filters, syringe filters, vacuum filtration units, capsule filters, depth filter pods, and similar single-use filter products. Sellers must declare product grade and, for GMP/Bioprocess Grade listings, provide extractables data, USP <88> or ISO 10993 biocompatibility results, and bacterial retention or LRV validation data where applicable.

• Pre-packed single-use chromatography columns - columns intended for single-cycle or limited-use processing in downstream bioprocessing. Sellers must provide a Certificate of Analysis for each column lot, including packed-bed qualification data, endotoxin and bioburden test results, residence time distribution data, and shipping validation confirmation. GMP-grade listings additionally require ISO 13485 certification and evidence of GMP-compliant packing environment.

Conditionally Permitted Products

The following categories may be listed only subject to additional documentation and verification requirements and, where applicable, ExuraBio's prior written approval:

• Export-controlled instruments, equipment, or materials subject to the Export Administration Regulations (EAR) or International Traffic in Arms Regulations (ITAR): subject to end-use certification and applicable export licensing requirements before listing approval.

• Radiation-producing equipment and radioactive material storage units: permitted only for institutional Sellers with valid NRC or agreement state licenses, and Buyers with appropriate licensing documentation.

• Select agent containment equipment (e.g., Class III biosafety cabinets, specialized containment systems): permitted only for verified institutional Sellers and Buyers with documented Select Agent Program registrations.

• Surplus materials or equipment from decommissioned government or federally funded laboratory programs: permitted subject to Seller providing documentation of lawful decommissioning, applicable property disposition authority, and compliance with applicable federal property regulations.

• High-powered lasers (Class 3B and Class 4): permitted only for institutional Sellers and Buyers with documented laser safety officer oversight and institutional safety programs in place.

Prohibited Products

Zero Tolerance: The following categories are strictly prohibited on the ExuraBio Platform under all circumstances. Listings may be removed immediately, and Seller accounts may be suspended or permanently terminated.

Finished Drug Products and Patient-Use Biologics

• Finished pharmaceutical drug products intended for human or veterinary therapeutic, prophylactic, or diagnostic use, including any material subject to DSCSA (Drug Supply Chain Security Act) chain-of-custody requirements.

• Active pharmaceutical ingredients (APIs) and drug substance intermediates.

• Biologics, vaccines, or cell therapy products intended or labeled for patient administration.

• Prescription drugs or controlled substances as defined under the Controlled Substances Act.

• Human blood, blood components, or primary human tissues intended for transplantation or clinical use.

• In vitro diagnostic (IVD) devices or test kits intended for clinical patient diagnosis.

Controlled Substances and Prohibited Chemicals

• Controlled substances and Schedule I–V substances under the Controlled Substances Act — ExuraBio permanently and unconditionally prohibits facilitation of controlled substance transactions. This prohibition is not subject to future revision.

• DEA List I and List II controlled substance precursor chemicals.

• Explosives, pyrophoric materials, or oxidizers classified as hazardous materials beyond standard laboratory-grade chemicals.

• Dual-use materials with potential biological weapons applications as defined under the Biological Weapons Anti-Terrorism Act and applicable export control regulations.

• Unlicensed or unregistered select agents or toxins.

Counterfeit, Adulterated, and Misrepresented Products

• Counterfeit, adulterated, relabeled, or fraudulently documented products of any kind.

• Products listed under a manufacturer's name or brand without the authorization of the brand owner.

• Products whose certificates of analysis, lot documentation, storage records, or specifications are falsified, altered, or materially inaccurate.

• Materials with expired certificates of analysis where the Seller cannot provide current testing to confirm continued quality.

Other Prohibited Items

• Products subject to an active FDA recall, safety alert, or regulatory hold at the time of listing.

• Live animals or animal-derived products subject to USDA APHIS import/export restrictions.

• Consumer goods, food, beverages, or non-laboratory personal items.

• Software or digital products not directly associated with, and transferable in connection with, a permitted laboratory instrument listed on the Platform.

Reporting Suspected Violations

Any User who identifies a listing that appears to violate this Product Scope Definition is encouraged to report it immediately using the "Report Listing" function on the Platform or by emailing compliance@exurabio.com. ExuraBio may review such reports and take action it deems appropriate, including listing removal, account suspension, or referral to regulatory authorities.

Policy Updates

ExuraBio may update this Product Scope Definition at any time to reflect changes in applicable law, regulatory guidance, or Platform policy. Material changes will be communicated to registered Sellers at least 14 days in advance. Sellers are responsible for reviewing their listings following policy updates