WYATT_1767908.docx

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

Project Title: Maintenance agreement for Various light scattering Equipment Support.

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): _Wyatt Corporation_______________________________

· Sequence number(s), if available: ____1637259________________________________

· Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: ____1767908______________ C. Total estimated dollar value of the requirement (including options, if applicable): ______$24,714.00______ D. Period of performance, inclusive of options: from _02/05/2016__________ to _02/04/2017_______________ 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.

F. Project Description

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, formulation, quality control, preclinical testing, and clinical trials. The light scattering and differential refractive index detectors charatcterize the recombianant proteins and protein conjugates that are presant as part of of the Vaccinalolgy research.

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)

Wyatt Technology Corp 6300 Hollister Avenue, Santa Barbara, CA 93117

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

These support contracts maintain various light scattering and differential refractive index detectors that are CRITICAL to characterizing the recombinant proteins and protein conjugates that are made as part of the mission of the Laboratory of Malaria Immunology & Vaccinology.

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

The equipment manufacturer is the only vendor qualified to maintain the specialized equipment. They have the Certified Technicians to repair these sensitive detectors, and perform the same quality control with every annual service of the instruments that they would do before shipping out new instruments. The equipment parts are not distrubited to other companies for resale and to use no manufacturer parts would viod the warrenty.

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):

See Market Research

VI. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Requestor Certification

Contracting Officer Approval