Sole_Source_JOFOC.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Purchase of Maintenance Contract with Waters Corporation

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

☒ New requirement ☐ Follow-on

· Name of the previous contractor(s):

· Sequence number(s), if available:

· Was the initial and any subsequent awards competed? ☐ Yes ☐ No B. AMBIS Sequence number for this requirement: 1737921 C. Total estimated dollar value of the requirement (including options, if applicable): _$22,349.80 D. Period of performance, inclusive of options: from _07/01/2015_ to _06/30/2016_ E. Project Background:

The Laboratory of Malaria Immunology and Vaccinology (LMIV) was commissioned in 2009 to conduct basic and applied research relevant to malaria immunology and vaccine development, to pursue novel vaccine concepts, to produce prototype malaria vaccines, and to conduct early-phase clinical trials of promising vaccine candidates. Our overarching goal is to develop malaria vaccines that will reduce severe disease and death among African children and pregnant women and will eliminate malaria from low-transmission areas of the world.

LMIV Vaccine Development Unit develops and performs clinical evaluation of prototype malaria vaccines. Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, analytical characterization of vaccine candidates, formulation, quality control, preclinical testing, and clinical trials.

F. Project Description

LMIV owns one Waters Xevo G2 QTOF Mass Spectrophotometer and associated UPLC. This instrument is used on a regular basis to analyze vaccine candidates for quality and purity. We require this instrument to be maintained on an annual basis as it contains highly sensitive componenets that are only serviceable by factory trained and qualified employees. This request is for a renewal of the existing service contract that expires on June 30, 2015. This instrument requires frequent service and advice from Waters service technicinans to keep it in operational status. Our current vaccine candidates must be analyzed on this instrument due to their specific design. One PM visit with the 20% off of parts when needed is sufficient for LMIV’s requirements.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s)

Waters Technologies Corporation 34 Maple Street Milford MA 01757 800 252 4752

B. Describe why only the requested supply/service will meet the government’s needs

Due to the highly specific and sensitive components found in this instrument only parts from the manufacturer can be used during a repair. This manufacturer does not sell or distribute the parts for this instrument to other vendors. Only qualified, certified Waters trained sevice technicians are able to troubleshoot and repair the Waters Xevo Mass Spec. This instrument has many sensitive and delicate compnents that only a qualified Waters technician is able to repair, replace and service.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

Only Waters sells and distributes the parts for the Xevo G2 mass spec. Only Waters trained technicians are able to service, repair and replace the parts found in this instrument. LMIV requires only Waters certified technicians to work on this particular instrument.

V. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The price is determined to be fair and reasonable based on (provide a narrative describing how the determination was made and the rational for the determination):

Award section