Brand Name or equal purchase of a computer perpetual license for HALO Image Analysis Platform

COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. RFQ-NCI-5389385 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2019-05 (August 2019) simplified procedures for commercial items. This requirement is assigned North American Industry Classification System (NAICS) code 541511 with a size standard of $27.5M. Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract. BACKGROUND The Laboratory of Human Carcinogenesis (LHC) is a lab that investigates the molecular causes and therapeutic approaches to cancer. Specifically, the Liver Cancer Section (LCS) conducts large-scale, genome-wide analyses on numerous human patient sample cohorts and validates key signaling pathways that promote liver cancer in in vitro and in vivo models. Liver cancer is one of the few neoplastic malignances to increase in overall mortality each year. Thus, LCS as a lab focuses on identifying key molecular drivers that promote liver cancer to provide greater therapeutic alternatives to combat this highly aggressive disease. In order to further LCS's understanding of liver cancer, the lab implores current and state of the art technologies to answer meaningful questions that can help future patients. Given that the lab has tissue from multiple liver cancer cohorts, with a large amount sectioned as tumor microarrays (TMA), it is imperative to utilize high-throughput approaches to quantify patient tumor samples, specifically at the single-cell level Tumor heterogeneity, or the diverse expression of different genes and proteins that leads to different genotypes and phenotypes of cancer cells, is a large conundrum in cancer research and medicine. For decades, it has been known that no two cancer cells are alike making it difficult to treat not just different patients with the same cancer type but each individual's response to treatment varies dramatically over time. Currently, cancer therapeutics are designed to target common mutations in different cancer types, assuming that all the cells have these specific mutations, which in reality is not the case. These assumptions have been made based on what is termed "bulk analysis" in which the expression of certain markers is examined as one entity. However, patients continue to relapse and therapy resistance is a large and growing problem in most cancer types, specifically liver cancer, the type LCS's lab focuses on. Thus, it is imperative to dissect the molecular features of a tumor at the single-cell level to get a more representative picture of the genomic makeup of each patients' tumors. Then molecularly-targeted treatment, commonly termed "precision medicine," will be implemented to ensure the best outcomes for patients. The LCS is requesting to purchase of a computer perpetual license for HALO Image Analysis Platform. HALO by Indica Labs is very unique software in which quantification of tumor markers can be analyzed at the single-cell level as well as spatially to determine which and where these markers are commonly expressed. Through this analysis, LCS can identify the exact genes that contribute to tumor heterogeneity and then conduct functional assays to determine how they lead to tumor growth. If successful, LCS can then develop a drug that targets these genes and potentially begin a clinical trial. Thus, this software has large translational implications that can allow scientists and clinicians to better understand why certain patients respond to treatment and others fail to show any tumor remission. The salient characteristics that apply to this acquisition are as follows: The following product features/characteristics are required for this requirement: - Must have a multifunctional ability to analyze images that allows users to spend less time learning software and more time analyzing data. The HALO software is a flexible, purpose-built modules provide quick, quantitative results in oncology, neuroscience, metabolism, toxicological pathology, and more. The design of this software is very unique because it allows you to use the distinct modules described below in Module Differentiators section. - Flexible usage tools and distinct modules that can be used independently or jointly to select regions of interest either automatically or partially manual. Use of a magnet pen tool is available to automatically choose specific areas of tissue or the fill tool can be used to select the whole tissue for analysis. These tools allow you to easily redraw, amend, move, rotate or copy-paste existing selections. These tools also allow you to train the software to automatically select your specific defined areas of interest across all images in a study. Provides multiple cores for processing data as a standard option with no additional cost. This feature facilitates faster processing for very large images. Digital images of slides are quite large and can over task conventional analysis systems. The multiple core technology and tested methods used by HALO provide 4 times greater processing speed compared to other systems. - HALO reports morphological and multiplexed expression data on a cell-by-cell basis across entire tissue sections and maintains an interactive link between cell data and cell image. Click on any cell in the image and immediately see analysis outputs for that specific cell. Sorting and filtering capabilities allow the user to mine millions of cells while visually assessing corresponding cell populations. For example, sort cells according to biomarker intensity and immediately locate cells with highest intensity in the image. The cell data includes XY positional information to facilitate spatial plotting and analysis. HALO delivers both shape and form data as well as detailed expression data on a cell-by-cell basis across the entire section of interest. HALO allows you to link the cell data with the cell image. You can click on any cell in the image and immediately see data output for that specific cell. You are able to visualize millions of defined cells in a population by using the sorting and filtering tools. For example, you could determine which cells have the highest level of intensity for a specific biomarker of interest and locate them on the entire section. The location tool includes horizontal and vertical information so exact location data can be plotted and graphs can be created. - 5 Module Differentiators: o TISSUE CLASSIFER -. Two tissue distribution tools can use different analysis technologies. Examples of the two classifier technologies used are Random Forest and Deep Neural Net. o MULTIPLEX IHC - o Ability to analyze up to 5 cell-based markers together in brightfield as opposed to other multiplex systems that only offer 3 markers. This ability allows HALO to interact with new, cutting-edge immunohistochemistry assays. HIGHPLEX FL - Ability to analyze up to 8 cell-based markers in fluorescence as opposed to other systems that only detect maximum 4 fluorescence dyes. This ability allows HALO to handle the multi-pictorial images created when other platforms are integrated o ISH AND ISH IHC - HALO uses In situ hybridization, which allows you to localize a specific RNA or DNA of interest in a sample, and integrates scoring and multiplex technologies. This combination of technologies allows you to analyze more probes as well as anu immunohistochemistry markers of interest. o SPATIAL ANALYSIS TOOLS - Plot cells from one slide or from multiple serial sections on a single spatial plot and 1) measure the distance between tumor cells and immune cells or 2) quantify the density of immune cells within a certain distance of the tumor cell compartment. - Must include a minimum of 12-month manufacturer warranty. Online support for the first 12 months if needed. - Must include training and installation or download instructions. - Quote must include shipping (if applicable), including any installation cost. NCI will not be responsible for any cost not included. DELIVERY / INSTALLATION The Contractor shall deliver and install the required item(s) within 5 days of purchase order award to the following location: NIH/NCI Bethesda, Maryland 20892. The Contractor that receives the award will be provided with the complete mailing address and point of contact. Upon award, contractor must notify the NCI Technical Point of Contact to schedule the delivery. TRAINING The Contractor must train 2 users in the laboratory. This shall be done remotely, through WebEx at a mutually available time between the Specialist and the users after installation of the software Training should occur within 5 business days after instrument installation. PAYMENT Payment shall be made upon the delivery, installation, training and acceptance of all required items. CONTRACT CLAUSES/PROVISIONS The following Federal Acquisition Regulation and Health & Human Services Acquisition Regulation Provisions/Clauses apply to this acquisition: The following FAR Clauses/Provisions are incorporate as required by the John S. McCain National Defense Authorization Act (NDAA) for FY 2019, Public Law 115-232, Section 889(a)(1)(A). The following FAR Clauses/Provisions are hereby added as an attachment and must be certified in response FAR 52.204-24 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment FAR 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. Clause No. Title FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS- COMMERCIAL ITEMS (OCT 2018) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018) HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY (DEC 2015) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS- COMMERCIAL ITEMS (AUG 2019). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition: FAR Clause 52.203-6 Restrictions on Subcontractor Sales to the Government FAR Clause 52.203-13 Contractor Code of Business Ethics and Conduct FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment FAR Clause 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.209-9 Updates of Publicly Available Information Regarding Responsibility FAR Clause 52.219-8 Utilization of Small Business Concerns FAR Clause 52.219-28 Post Award Small Business Program Representation FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities FAR Clause 52.222-37 Employment Reports of Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union Dues or Fees FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade Act FAR Clause 52.225-5 Trade Agreements FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award Management FAR 52.211-6 BRAND NAME OR EQUAL (AUG 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. (c) The Contracting Officer will evaluate "equal" products based on information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. HHSAR 352.203-70 ANTI-LOBBYING (DEC 2015) Pursuant to the current HHS annual appropriations act, Public Law 112-74, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for: (a)Publicity or propaganda purposes; (b)The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself; or designed to support of defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local government, except in presentation to the executive branch of any State or local government itself; or (c)Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations regulation, administrative action, or Executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government is policymaking and administrative processes within the executive branch of that government. The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future Federal, State or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control. SUBMISSION INFORMATION Proposals must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of valid certification in the System for Award Management (SAM) at www.sam.gov. Questions must be submitted electronically (via email) to Lisa Hill, CCR Purchasing at lisa.hill@nih.gov. in MS Word or Adobe Portable Document Format (PDF), no later than September 3, 2019, 11:00 am, EST. Proposals must be submitted electronically (via email) to in MS Word or Adobe Portable Document Format (PDF), no later than September 6, 2019 to Lisa Hill, CCR Purchasing at lisa.hill@nih.gov @ 11:00 am, EST. All responses must be received by the specified due date and time to be considered. PROPOSALS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls will be accepted. Please refer to solicitation no: RFQ-NCI-5389385 in all correspondence. EVALUATION The award decision will be based on a Lowest Price Technically Acceptable (LPTA) determination. Award will be made on all or none basis. If you are providing an "equal" product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6. PRICE PROPOSAL The quoters shall prepare a price proposal that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large).