Induced pluripotent stem (iPS) cell-derived differentiated cells
INTRODUCTION This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 621111 Offices of Physicians (except Mental Health Specialists) with size standard 11,000,000 million USD. BACKGROUND The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Center for Advancing Translational Sciences (NCATS) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Tissue BioPrinting Group at NCATS is invested in developing therapeutically relevant tee-dimensional tissues for basic research and drug screening. One of the greatest promises of human stem cells is to transform these early-stage cells into treatments for devastating diseases. Stem cells can potentially be used to repair damaged human tissues and to bioengineer transplantable human organs using various technologies, such as 3D printing. Using stem cells derived from another person (allogeneic transplantation) or from the patient (autologous transplantation), research efforts are underway to develop new therapies for historically difficult to treat conditions. In the past, adult stem and progenitor cells were used, but the differentiation of these cell types has proven to be difficult to control. Initial clinical trials using induced pluripotent stem (iPS) cells indicate that they are far superior for cellular therapy applications because they are better suited to scientific manipulation. Experts at NCATS are applying the techniques of 3-D printing to develop tissue models that mimic the 3-D structure and organization of cells in the tissues of living organisms. The Tissue BioPrinting Lab is using the iPS cells to bioprint 3D tissue models of the brain to study the effects of new therapies for pain, opioid addiction and overdose. With these cells, scientists at NCATS are developing human 3D tissue models, and the only source of obtaining large amounts of human dopaminergic, gabanergic and glutaminergic is tough differentiation of iPSC cells. Purpose and Objectives This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement, which is to obtain iPS cell-derived differentiated cells on a BRAND-NAME-OR-EQUAL basis to the iPS cell-derived differentiated cells, or their equal, described in this notice that are manufactured by FUJIFILM CELLULAR DYNAMICS, INC. located at 525 Science Drive, Madison, WI 53711. Project Requirements Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the essential government features specified herein. Products offered must include those salient physical, functional, or other characteristics of the iPS cell-derived differentiated cells, manufactured by FUJIFILM CELLULAR DYNAMICS, INC., which are deemed essential in meeting the government's needs. Specifically, the following Product Item numbers and features are considered essential for this potential requirement to achieve: 1. R1108: induced pluripotent stem cell (iPSC) - derived dopaminergic (DA) neurons, supplied as 3 vials with approximately 1 million cells each 2. R1032: iPSC - derived DA neurons, supplied as 1 vial with approximately 5 million cells 3. NRC-100-010-000.5: iPSC - derived GABAergic (GABA) neurons, supplied as 1 vial with approximately 2 million cells 4. R1013: iPSC - derived GABAergic neurons, supplied as 1 vial with approximately 4 million cells 5. R1116: iPSC - derived glutamatergic (gluta) neurons, supplied as 3 vial with approximately 1 million cells each 6. R1034: R1116: iPSC - derived glutamatergic neurons, supplied as 1 vial with approximately 6 million cells 7. R1112: iPSC-derived endothelial cells (EC), supplied as 1 vial with approximately 1 million cells 8. M1019: media supplement for growing iPSC-derived ECs 9. M1029: media supplement for growing iPSC-derived DA neurons 10. M1031: media supplement for growing iPSC-derived neuronal cells (DA, GABA, and gluta) 11. M1032: media supplement for growing iPSC-derived GABAergic neurons Products offered must be essentially equal to the specified supply described in this announcement, which specifically includes the following Product Number, Description, No. of neurons per unit, no. of vials per unit, and Quantity, manufactured by FujiFilm Cellular Dynamics, Inc. 1. R1108, DA 3x1M, 3, 3, 17 2. R1032, DA 5M, 5, 1, 50 3. NRC-100-010-000.5, GABA ~2M, 2, 1, 25 4. R1013, GABA 4M, 4, 1, 50 5. R1116, Gluta 3x1M, 3, 3, 15 6. R1034, Gluta 6M, 6, 1, 30 7. R1112, ECs 1M, 1, 1, 25 8. M1019, EC supp, 0, 0, 20 9. M1029, DA sup B, 0, 0, 30 10. M1031, NSS, 0, 0, 30 11. M1032, GABA sup A, 0, 0, 20 Delivery: Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or factory warranty schedules in accordance with standard commercial practice, as applicable. Shipping shall include FOB-destination. Inspection and acceptance will be performed at a Government facililty located at 9800 Medical Center Drive, Rockville, MD 20850. CAPABILITY STATEMENTS/INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order. Respondents that believe that they are manufacturers or authorized re-sellers of the equipment specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required. The response is limited to fifteen (15) pages. This page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Respondents must reference the subject announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement. CONCLUDING STATEMENTS Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). .
75N95019Q00140 Department of Health and Human Services National Institutes of Health
4/22/19, 5:55 PM Induced pluripotent stem (iPS) cell-derived differentiated cells
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95019Q00140 and the solicitation is issued as a Request for Quotation (RFQ) on a Full and Open competitive basis. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items. This acquisition is expected to exceed the simplified acquisition teshold of $250,000.00. A Fixed-Price type of contract is contemplated for any resulting contract entered into as a result of this solicitation. (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) Number/Effective Date: 2019-02 / 05-06-2019. (iv) The North American Industry Classification System (NAICS) code for this procurement is 621111 Offices of Physicians (except Mental Health Specialists) with size standard 11,000,000 million USD. This requirement is released with no set-aside restriction. (v) This requirement is for the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). NCATS has a requirement to obtain iPS cell-derived differentiated cells on a BRAND-NAME-OR-EQUAL basis to the iPS cell-derived differentiated cells, or their equal, described in this notice that are manufactured by FUJIFILM CELLULAR DYNAMICS, INC. located at 525 Science Drive, Madison, WI 53711. The Tissue Bioprinting Group at NCATS develops therapeutically relevant tee-dimensional tissues for basic research and drug screening. Human stem cells transform early-stage cells into treatments for devastating diseases. Stem cells can potentially be used to repair damaged human tissues and to bioengineer transplantable human organs using various technologies, such as 3D printing. Research seeks to develop new therapies for historically difficult to treat conditions using stem cells derived from another person (allogeneic transplantation) or from the patient (autologous transplantation). In the past, adult stem and progenitor cells were used, but the differentiation of these cell types has proven to be difficult to control. Initial clinical trials using induced pluripotent stem (iPS) cells indicate that they are far superior for cellular therapy applications because they are better suited to scientific manipulation. Experts at NCATS are applying the techniques of 3-D printing to develop tissue models that mimic the 3-D structure and organization of cells in the tissues of living organisms. The Tissue Bioprinting Lab is using the iPS cells to bioprint 3D tissue models of the brain to study the effects of new therapies for pain, opioid addiction and overdose. With these cells, scientists at NCATS are developing human 3D tissue models, and the only source of obtaining large amounts of human dopaminergic, gabanergic and glutaminergic is tough differentiation of iPSC cells. (vi) The purpose of this requirement is to obtain iPS cell-derived iCell(R) differentiated cells, or their equal, that are manufactured and produced by Fujifilm Cellular Dynamics, Inc. located at 525 Science Drive, Madison, WI 53711. The iPS cell-derived iCell(R) products are generated from cells, such as adult skin or blood, obtained from donors. They are delivered tough an episomal reprogramming process that utilizes circular DNA vectors to deliver the pluripotency genes. Specifically, this includes the following Product Number, Description, No. of neurons per unit, no. of vials per unit, and Quantity, manufactured by FujiFilm Cellular Dynamics, Inc: 1. R1108, DA 3x1M, 3, 3, 17 2. R1032, DA 5M, 5, 1, 50 3. NRC-100-010-000.5, GABA ~2M, 2, 1, 25 4. R1013, GABA 4M, 4, 1, 50 5. R1116, Gluta 3x1M, 3, 3, 15 6. R1034, Gluta 6M, 6, 1, 30 7. R1112, ECs 1M, 1, 1, 25 8. M1019, EC supp, 0, 0, 20 9. M1029, DA sup B, 0, 0, 30 10. M1031, NSS, 0, 0, 30 11. M1032, GABA sup A, 0, 0, 20 Products offered must include those salient physical, functional, or other characteristics that are deemed essential in meeting the government's needs. Specifically, the following features are deemed essential that this requirement shall achieve: 1. R1108: induced pluripotent stem cell (iPSC) - derived dopaminergic (DA) neurons, supplied as 3 vials with approximately 1 million cells each 2. R1032: iPSC - derived DA neurons, supplied as 1 vial with approximately 5 million cells 3. NRC-100-010-000.5: iPSC - derived GABAergic (GABA) neurons, supplied as 1 vial with approximately 2 million cells 4. R1013: iPSC - derived GABAergic neurons, supplied as 1 vial with approximately 4 million cells 5. R1116: iPSC - derived glutamatergic (gluta) neurons, supplied as 3 vial with approximately 1 million cells each 6. R1034: R1116: iPSC - derived glutamatergic neurons, supplied as 1 vial with approximately 6 million cells 7. R1112: iPSC-derived endothelial cells (EC), supplied as 1 vial with approximately 1 million cells 8. M1019: media supplement for growing iPSC-derived ECs 9. M1029: media supplement for growing iPSC-derived DA neurons 10. M1031: media supplement for growing iPSC-derived neuronal cells (DA, GABA, and gluta) 11. M1032: media supplement for growing iPSC-derived GABAergic neurons Offerors submitting a quotation must: 1) clearly indicate if the line item or items being offered in their quote is a brand-name item to the brand name item described in this solicitation, or if the item or items being offered is an "or-equal" item; 2) include Shipping and handling cost in the quotation or specify if it is included in the price; 3) indicate if items being quoted are warrantied in accordance with their standard commercial warranty practices, and the length of time of such warranty; 4) indicate an estimated delivery time in full after receipt of an order. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date after receipt of order (ARO) shall be specified in the offeror's quote and will be determined prior to any award. Delivery will be FOB destination. The place of delivery and acceptance will be 9800 Medical Center Drive, Rockville, MD 20850. DELIVERY SCHEDULE: Staggered delivery is required within a 12-month period from receipt of award by the vendor. Some flexibility in the below schedule may be required based on project status and recurrent needs of the laboratory. Fixed-price Cost schedule: Month 1, Delivery 1 - $TBD; Month 4, Delivery 2 - $TBD; Month 7, Delivery 3 - $TBD; Month 10, Delivery 4 - $TBD. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.211-6, Brand Name or Equal (Aug 1999) FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018). The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (OCT 2018) is applicable to this solicitation: 52.203-6 Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct1995) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-8 Utilization of Small Business Concerns (Nov 2016) 52.219-28 Post Award Small Business Program Rerepresentation (Jul 2013) 52.222-3 Convict Labor (June 2003) 52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sep 2016) 52.222-35 Equal Opportunity for Veterans (Oct 2015) 52.222-36 Equal Opportunity for Workers With Disabilities (Jul 2014) 52.222-37 Employment Reports on Veterans (FEB 2016) 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) 52.222-50 Combating Trafficking in Persons (Mar 2015) 52.222-54 Employment Eligibility Verification (OCT 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-1 Buy American - Supplies (May 2014) 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008) 52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Jul. 2013) The following provisions and clauses apply to this acquisition and are incorporated as an attachment: NIH Invoice and Payment Provisions (2/2014) (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The following is an addendum to 52.212-2. Responses received to this RFQ will be evaluated on the basis of Lowest Price Technically Acceptable (LPTA). Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty and training considerations. Responses will be evaluated based on contractor's ability to meet the government's SALIENT CHARACTERISTICS stated in this notice and on ability to deliver required supplies. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the essential government requirements stated in this solicitation. Under the lowest-price technically acceptable (LPTA) process, Offerors' will be determined to be "technically acceptable" or "technically unacceptable" based on an evaluation of responses against the following factor to determine if, as submitted, the proposal is technically acceptable. (1) Technical Capability: Offerors shall clearly indicate possessing the technical capability to achieve the essential salient characteristic features of this requirement. The Offeror must indicate in its quotation the ability to provide all of the requirements. The Offeror must indicate in its quotation the ability to meet the delivery requirements. Offerors submitting a response with documented technical specifications and evidence of possessing the technical knowledge, qualifications and capability and management structure needed in successfully achieving the SALIENT CHARACTERISTICS identified in this requirement will be determined to be technically acceptable. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text. (xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. Respondents proposing on an equal product of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. (xvi) All responses must be received no later than the date specified in this announcement. Late responses will not be accepted. All responses must reference the subject solicitation number. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-827-5304..
75N95019Q00140 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
6/19/19, 10:34 AM