Q A_1144375.doc

Questions and Answers for FDA-SOL-1144375 Q.1 We would like to confirm that we should quote the HDX Technology option and NOT the HDX Automation option. A description of the differences is below, with the main difference being the LEAP automation manager included with the HDX Automation option.

ACQUITY UPLC M-Class System with HDX Technology

Supplies direct (non-split) capillary and nanoflow for high-resolution chromatographic separations optimized for columns ranging from 75 micron to 1 mm internal diameter. This system is for use in the hydrogen deuterium exchange (HDX) reaction to determine changes in protein conformation.

The following items are included as part of the ACQUITY UPLC M-Class System with HDX Technology:

· ACQUITY UPLC M-Class Binary Solvent Manager (BSM) (186016003)

· ACQUITY UPLC M-Class HDX Manager (replaces sample manager) (186016013)

· ACQUITY UPLC M-Class Auxiliary Solvent Manager (ASM) (186016022)

· ACQUITY UPLC M-Class HDX system manual start-up kit (200000351)

ACQUITY UPLC M-Class System with HDX Automation The following items are included as part of the ACQUITY UPLC M-Class System with HDX Automation:

· ACQUITY UPLC M-Class Binary Solvent Manager (BSM) (186016003)

· ACQUITY UPLC M-Class HDX Manager (replaces sample manager) (186016013)

· ACQUITY UPLC M-Class Auxiliary Solvent Manager (ASM) (186016022)

· ACQUITY UPLC M-Class HDX system start-up kit (200000351)

· Leap HDX Automation Manager HDX Director (725000584)

· ACQUITY UPLC M-Class HDX Shelf (205016041)

· ACQUITY UPLC M-Class HDX system automation start-up kit (200000352)

Also, we would like to confirm that both the DynamX HDX and PLGS (Proteinlynx Global Server) software be included in the quote. Both of these software options are necessary for HDX analysis."

Thank you in advance for your response.

A.1:Yes, the HDX technology option (WITHOUT automation) is what is requested. Only the DynamX HDX software need be included in the quote as the FDA already has the PLGS software package.

Q.2: We have some questions on this requirement; the specifications ask for the following:

A nanospray ionization (nESI) source compatible with an existing Waters Acquity I-Class UPLC- Synapt G2si MS system at DPA.

But the bid title and specifications listed under 3.2 are for a UPLC. Can you clarify, do you want a nESI source, or a UPLC or both?

A.2: The bid title and specifications are correct, this request is for a UPLC that is compatible with an existing Synapt G2si MS system with an ESI source. While it also has a nESI source, that is interchangeable and not essential to this request and unintententionally included.