The listed tasks will be performed on an on-going basis throughout the contract life. a. Storage- Storage of the approximately 135,000 compound CBCSLC library in a suitable facility under conditions that ensure optimal stability and purity, along with background tasks related to the maintenance of associated infrastructure. The library collection is maintained as a mix of: 1) 4 dram vialed neat solid/films, 2) working solution stores in Matrix tubes and 3) 384-well microtiter plates. The Contractor shall have the capability to store all samples long-term at -78, -20, and 0C under inert atmosphere as appropriate for maintaining quality in a cost effective manner. The standard storage conditions are -20C under an inert atmosphere employing DMSO as a solution solvent. There shall be sufficient storage space and flexibility to accommodate changes in the mix of storage types. The Contractor shall provide all the necessary expertise, equipment, and facilities to store, maintain, and track the inventory. Storage and handling shall comply with all applicable local, state and Federal regulations. ? ANY AND ALL COMPOUNDS SUPPLIED OR PURCHASED UNDER THIS CONTRACT, STORED AS SOLIDS, SOLUTIONS OR PLATED, SHALL REMAIN THE PROPERTY OF THE GOVERNMENT THROUGHOUT THE LIFE OF THE CONTRACT. THE CONTRACTOR SHALL TRANSFER THESE COMPOUNDS TO THE FOLLOW-ON CONTRACT SHOULD ONE BE ISSUED OR TRANSFER THE COMPOUNDS TO THE APPROPRIATE FACILITY AS DIRECTED BY THE CONTRACTING OFFICER OR HIS REPRESENTATIVE. See section K of this SOW - b. Quality Control ? The Contractor shall perform rapid, low throughput analyses of chemical purity (e.g., LC/MS, HPLC, and/or NMR) as requested by the COR. It is anticipated that this will involve 50-250 samples annually. The Contractor shall be required to have an on-going Quality Assurance plan for instruments and other equipment. The QC requirement (purity and identity) shall include but is not limited to ability to carry out high throughput analysis by GC-MS or LC-MS and interpret results as passing or failing to meet QC criteria by showing specified purity (as specified by the COR). The primary method of analysis shall be LC-MS and/or GC-MS. When these methods are not suitable the Contractor shall have the capability to routinely perform purity analysis by 1H-NMR. It is anticipated that <1% of samples will require 1H-NMR analysis. Structure not confirmed by lack of observed molecular ion by MS or NMR spectra inconsistent with structure is deemed as failing. c. Distribution ? The Contractor shall have the capability to ship plated sets (e.g. diversity library, focused libraries and single-use sets) to the CBC screening centers and external investigators, as requested by the COR. The Contractor shall have capability to ship on a weekly basis using ?next business day? for domestic shipments. The Contractor shall also have the capability to ship internationally including regions in India and China. It is estimated that international shipments will be minimal. It is anticipated that 10-15 institutes will comprise the CBC including 5-8 screening centers. Compound shipments shall be made in such a way as to ensure the integrity of the contents (e.g. packed in dry ice) and shall comply with all applicable federal, state, and local regulations and international shipping and custom regulations. It is anticipated that 15-20 individual shipments will be made annually that include existing libraries and cherry-picked sets. The direct shipping costs will be charged to the recipient through their Fedex number while the cost associated with packaging will be the responsibility of the Contractor. d. Inventory Monitoring and Repurchase- The Contractor shall monitor and maintain adequate compound inventory, both solution and dry store, to ensure that sufficient threshold quantities, as specified by the COR, of all compounds are available to support screening needs. As compounds fall below threshold inventory (e.g. 5 mg), either by depletion or degradation, the Contractor shall undertake all activities necessary to purchase sufficient quantities of the compound to replenish the inventory upon approval by the COR. It is anticipated that no more than 0.5% of the sample collection will need to be replenished annually. It is estimated that this would be ~300 compounds over the life of the contract. e. CBC Synthetic Compounds ? The Contractor shall also have the capability to manage CBC member generated dry powder synthetic samples. It is anticipated that the number of compounds will be minimal over the life of the contract (i.e. <50). Management of samples will involve receipt, registration, inventory, storage, analysis and distribution activities. f. Disposal ? The Contractor shall comply with all local, state and Federal regulations in the disposal of chemical samples, personal protective equipment, solvents and chemically contaminated vials, tubes and plates. g. Informatics and Documentation - The Contractor shall maintain and update the CBCSLC electronic database containing individual chemical structures, descriptors, associated physiochemical data along with distribution and inventory information. The Contractor?s database shall be functionally compatible with the internal Oracle-based NCI/CBC database. The Contractor shall be responsible for regularly synchronizing the CBC-related information between the databases. In addition, the Contactor shall produce archival documents that describe the design history, physiochemical characteristics and content of new libraries added to the collection over the life of the contract.
