(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 threshold 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 through 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 three-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 through 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 through 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 [email protected]. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at [email protected] or by phone at 301-827-5304.