D.1 SOW.pdf

STATEMENT OF WORK (SOW)

General Information

Title of Project:

Support Plan for Thermo Scientific instrumentation: (1) Q Exactive HF-X Mass Spectrometer;

(2) Vanquish Binary Pump H. Supports high-sp; (3) Vanquish Split Sampler HT; and (4)

Vanquish Column Compartment H. Supports for the Absorption, Distribution, Metabolism and

Excretion (ADME) bioanalytical group in Therapeutics for Rare and Neglected Diseases (TRND).

Statement of Need and Purpose:

This requisition is for Support Plan for preventative maintenance and emergency parts of for

Thermo Scientific instrumentation in ADME bioanalytical laboratory.

Background Information and Objective:

The Therapeutics for Rare and Neglected Diseases (TRND) program’s mission is to encourage and speed the development of new treatments for diseases with high unmet medical needs.

TRND stimulates therapeutic development research collaborations among NIH and academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses.

ADME group facilitates drug discovery from the basic research lab to the pre-clinical stage.

Picking up where our Probe Development Group work leaves off, TRND will concentrate its efforts on the pre-clinical stage of drug development, where researchers develop clinical candidate in preparation for human testing. In doing so, TRND will help bridge the wide gaps in time and resources that often exist between basic research and clinical testing of new drugs. It is expected that in most cases, TRND’s clinical candidates will be licensed to biopharmaceutical companies for further development, thus allowing TRND to focus on the scientifically challenging pre-clinical stages of the drug development, and “de-risking” the projects sufficiently to make them adoptable by private sector companies.

To keep working towards this goal, TRND requires a support plan for Thermo Scientific instrumentation in the lab. The support plan agreement shall cover all items listed in this

Statement of Work.

Period of Performance:

The period of performance shall be 10 months for Base Period, with an Option Period of 12 months.

- Base Period: 06/19/2021 - 04/22/2022;

- Option Period 1: 04/23/2022 – 04/22/2023.

Scope of Work

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. Instrument: Q Exactive HF-X Mass Spectrometer Part Number: 0726042 Serial Number: SN06486L Support Plan: Unity essential support plan MSPEC-LC-MS

2. Instrument: Vanquish Binary Pump H. Supports high-sp

Part Number: VH-P10-A-02

Serial Number: 8310520

Support Plan: Unity essential plan CHROM-LC-DNX

3. Instrument: Vanquish Split Sampler HT

Part Number: VH-A10-A-02

Serial Number: 8310358

Support Plan: Unity essential plan CHROM-LC-DNX

4. Instrument: Vanquish Column Compartment H. Supports

Part Number: VH-C10-A

Serial Number: 6502479

Support Plan: Unity essential support plan CHROM-LC

5. Option: One 12-month Option Period for the support plan (Option Period 1)

Specific Requirements:

Unity essential support plan MSPEC-LC-MS Features:

1. Field Service Engineer labor, travel, and parts required for Corrective Maintenance visits with a targeted response time of 3 business days

2. Priority status for technical support inquiries with a targeted immediate response time. A certified service engineer will conduct diagnosis and Corrective Maintenance procedures using the latest digital remote support tools.

3. One (1) scheduled annual Preventive Maintenance (PM) visit (a standard PM kit is included). A Thermo factory trained engineer will replace all parts subject to wear at the time of each preventative maintenance as defined in the product specific PM checklist

4. Premium subscription to Unity Lab Services Online Knowledge Base

5. 10% discount on parts, accessories, and consumables during the effective period of the contract

6. Computers that were purchased from Thermo Fisher Scientific and required for the operation of the analytical system

7. Software and firmware updates upon request and in conjunction with a scheduled

Preventive Maintenance or Corrective Maintenance visit (updates are defined as changes of the existing software version that are intended to improve its performance)

Unity essential plan CHROM-LC-DNX Features:

1. Unlimited number of demand on-site service visits with a maximum 72-hour response

2. Engineer labor and travel is included

3. Priority status for technical support inquiries

4. One (1) Scheduled Preventative Maintenance visit. A Thermo factory trained engineer will replace all parts subject to wear at the time of each preventative maintenance as defined in the product specific PM checklist

5. Thermo Scientific supplied personal computers are covered

6. Factory-certified replacement parts included

7. Software updates and notifications

8. Subscription to e-Support Online Technical Resources

9. One time 10% discount on Parts, Accessories or Consumables for end user during active contract.

10. Software updates and notifications. Updates are defined as Software revisions that provide minor changes that are needed to correct or improve the previous version of the software. Software updates are normally indicated by a software revision number change e.g. version 1.1 to version 1.2.

11. Computers purchased from Thermo and are required for the operation of the system is covered under a Support Plan.

Unity essential plan CHROM-LC Features:

1. Field Service Engineer labor, travel, and parts required for Corrective Maintenance visits with a targeted response time of 3 business days

2. Priority status for technical support inquiries with a targeted immediate response time. A certified service engineer will conduct diagnosis and Corrective Maintenance procedures using the latest digital remote support tools

3. One (1) scheduled annual Preventive Maintenance visit (a standard PM kit is included).

A Thermo factory trained engineer will replace all parts subject to wear at the time of each preventative maintenance as defined in the product specific PM checklist.

4. Premium subscription to Unity Lab Services Online Knowledge Base

5. 10% discount on parts, accessories, and consumables during the effective period of the contract

6. Computers that were purchased from Thermo Fisher Scientific and required for the operation of the analytical system

7. Software and firmware updates upon request and in conjunction with a scheduled

Preventive Maintenance or Corrective Maintenance visit (updates are defined as changes of the existing software version that are intended to improve its performance)

Government Responsibilities:

Government shall provide contractor access to NCATS facilities: 9800 Medical Center Dr-Bldg

C-Rm 059, Rockville MD 20850. Access will be restricted during federal holidays and after business hours.

Delivery or Deliverables:

Contractor is responsible for providing the evaluation and repairs, including labor, parts and materials as required.

Reporting Requirements:

Contractor shall provide a field service report at the completion of each service.

Other Considerations:

Travel:

Travel may be required to the Government facility in which the equipment is installed, which it shall be covered by the contractor on its service plan price.