Stability Testing of NTM-1632 and NTM-1633

Task Order HHSN27200002 (B-001) was sole sourced to Nanotherapeutics, Inc. on fixed-priced basis: 1. Identification of the Agency and Contracting Activity: National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisition (OA) Microbiology and Infectious Disease Research Contracts Branch - A (MIDRCB-A) 2. Nature and/or description of the action being approved. In accordance with FAR 16.5, all orders that exceed the simplified acquisition threshold shall be placed on a competitive basis and fair notice shall be provided to all offerors in the IDIQ award pool. For this action, the NIAID will be sole sourcing RTOP B-001 entitled "Analytical Assay Development and Product Characterization" to Nanotherapeutics, Inc under contract HHSN272201600006I Task Order # HHSN27200002. 2. Description of the services required to meet the agency's needs (including the estimated value). a. Project title: "Stability Testing of NTM-1632 and NTM-1633" b. Description of Services: The activities to be performed under this Task Order is to perform product stability testing on NTM-1632 and NTM-1633 drug products. c. Estimated Value: The IGCE was developed based upon historical data. The estimated value of this Task Order is $585,000. 3. Identification of the exception to fair opportunity and supporting rationale: a. Statutory Exception to Fair Opportunity: Only one awardee is capable of providing the service required at the level of quality required because the services ordered are unique or highly specialized. b. Supporting Rationale: - Nanotherapeutics acquired NTM-1632 and NTM-1633 from Xoma in Nov 2015. - Xoma developed Xoma 3B and Xoma 3E (now called NTM-1632 and NTM-1633 respectively) Drug Products. During product development, analytical test methods were established for both Drug Products that were used to set quality parameters for product release and periodic stability testing. Data generated by Xoma from product release and previous stability test points has been or will be included in IND Module 3 CMC submissions to FDA. - Analytical test method development is a complex process that was completed by Xoma resulting in detailed precise procedures (SOPs) that must be followed to generate new data that can be directly compared to data from previous stability test points. Nanotherapeutics is the only Contractor in the Task Area B pool that has these test methods established. - Many of the methods require inclusion of an assay standard and comparison to results obtained for the standard. The assay standards were generated by Xoma; they are not available commercially, they are unique and proprietary and are only available to Nanotherapeutics. - Unique, proprietary assay reagents were developed for some test methods. The reagents were developed at UCSF and Xoma and are subject to IP and license agreements held by Xoma (now transferred to Nanotherepeutics). These assay reagents are not available commercially, they are unique and proprietary and are only available to Nanotherapeutics. - Data generated from the testing now required will be included in subsequent submissions to FDA and must be generated from the established test procedures now only available at Nanotherapeutics to support comparability to previous data and continuity.