(ii) The solicitation number is 75N95019Q00021 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- Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is NOT expected to exceed the simplified acquisition threshold (SAT) of $250,000.00. A Fixed-Price type of Purchase Order 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 Circular FAC Number/Effective Date: FAC_2005-101 / 10-26-2018

(iv) The North American Industry Classification System (NAICS) code for this procurement is 325998 - All Other Miscellaneous Chemical Product and Preparation Manufacturing with associated small business size standard of 500 employees.

(v) Background
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) 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 Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum.

The DPI is developing 3-D tissue models that more closely mimic the complexity of tissues in the human body in a reproducible, automated and scalable manner using bioprinting techniques to better predict how potential new drugs will affect humans. Specifically, DPI is focused on developing a 3D tissue of blood retina barrier (BRB) to mimic pathological conditions in age-related macular degeneration (AMD) using bioprinting technology and patient specific induced pluripotent stem cells (iPSCs). In this model, biodegradable scaffold plays a role as a substrate of both retina pigment epithelial (RPE) cells and bioprinting of choroid tissue including choriocapillaris. This scaffold is considered as a temporary Bruch's membrane, which is the basement membrane located between RPE and choroid. Bruch's membrane allows molecular interaction between RPE and choroid, and its thickness is about 2~4 µm. In wet form of AMD, vessel growth from choroid, choroidal neovascularization (CNV), compromises Bruch's membrane and RPE. Engineered tissue requires capability to show CNV and cell-to-cell interaction. To achieve these aims, the scaffold thickness is required to be as thin as Bruch's membrane, and the half-time of biodegradation needs to be approximately one month to allow cell communications during tissue development. In wet AMD model, these features of scaffold thickness facilitates access of molecules secreted by RPE to printed choroid, and biodegradation helps CNV development to reach RPE layer.

Purpose and Objective:
The purpose of this requirement is to obtain biodegradable poly (D,L-lactide-co-glycolide) (PDLGA) scaffold. Electrospun PDLGA scaffold is required for building multi-tissue layers including vascularized tissue and epithelium to mimic blood retina barrier (BRB), which requires pore size control, biodegradation period, retaining mechanical strength and bioprinting capability with bioink including multi cell types and epithelial cell monolayer formation. Biodegradation of scaffolds will be required for cell-cell communications and cell migration in disease models. An additional manufacturing step is required to get the final products of precut scaffolds with 10~12mm diameter, which will facilitate and accelerate the bioprinting process.

Product Description: The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to obtain the subject requirement that achieves the following specifications.

a. 10~12mm diameter pre-cut (laser cut) scaffolds from 9cm (W) x 10cm (L) of scaffold sheets containing ~500nm of electrospun nanofibers.
b. Thickness is less than 10 µm.
c. Pore size is less than 1.0 µm diameter to prevent from cell migration and to separate culture media from top to bottom without leakage for 3 weeks using pre- and post- thermal process.
d. Capable of maintaining mechanical strength at least for 3 weeks.
e. Half degradation time is about a month.

Specifically, the following salient characteristics are deemed essential that this potential requirement will achieve:

a. Small pore size to enhance tissue engineering capability including multi cell types;
b. Biodegradation of scaffolds to help integration of 3D tissue layers, which is a key feature to mimic cell-cell communications within tissues in various pathological conditions;
c. Is biocompatible, biodegradable, and bioprintable with bioink;
d. Capable of cell monolayer formation on the surface;
e. Each item should be properly sterilized and labeled, pursuant to the product description requirements set forth herein.

Contractors shall possess the technical capability to achieve the salient government characteristics of this requirement and document evidence of being able to provide the subject requirement that will allow for the essential features described herein to be achieved.

Period of Performance/Delivery:
Offerors shall indicate an estimated delivery time in full after receipt of an order and any other training or warranty provisions applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. Contractor will be required to deliver the subject supply about once every six (6) weeks with each delivery including eight (8) scaffold of 9cm (W) x 10cm (L) dimensions for a total of eight (8) deliveries.

GOVERNMENT RESPONSIBILITIES
The Government will review and approve the data, reports, and products generated.

DELIVERY OR DELIVERABLES
1. 0.2 grams of Marizomib, pursuant to the purity qualifications above
2. 1 report detailing the synthesis, and including purity information.

REPORTING REQUIREMENTS
1. Contractor will be expected to stay in e-mail contact with the government representative, with reports issued at least monthly.

Data Rights/Confidentiality of Information: Data may be produced as part of this contract. The government retains rights to this data. All data is the property of NCATS unless otherwise specified. Contractor will keep data generated strictly confidential. Any information the contractor is to release must be authorized by the government before release. Contractor will not write, nor publish articles, except with the express written permission of the government.

Inspection and Acceptance
Offerors should indicate an estimated delivery time in full after receipt of an order. Inspection and acceptance will be performed at NCATS, located at 9800 Medical Center Drive, Rockville, MD 20850.

(vi) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The following is provided as an addendum to FAR clause 52.212-1, Instructions to Offerors: Offerors should indicate an estimated delivery time in full after receipt of material to be tested.

(vii) 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 a trade-off basis. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Price is an unscored component. Technical Evaluation criteria when combined are significantly more important when compared to price. Each quotation will be evaluated in strict conformity with the evaluation factors, utilizing written critiques. The evaluation will be based upon the demonstrated capabilities of the prospective contractor in relation to the needs of the project as set forth in the RFQ and will use an adjectival evaluation rating scheme based on the following responses:

Excellent (Risk level: Very low); Good (Risk level: Low); Acceptable (Risk Level: Neutral); Marginal (Risk level: High); Unacceptable (Risk level: Very high).

(1) Technical Capability: Offerors shall clearly indicate possessing the 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 and the ability to meet the delivery requirements. Offerors will be evaluated based on documenting evidence showing an understanding of the work and possessing the required technical experience and capability of successfully performing this requirement.

Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must include FIXED-PRICES per unit and total fixed 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 required 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.

(viii) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition.

(ix) The provision at FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. No addendum to FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, Offeror Representations and Certifications Commercial Items, applies to this acquisition. No additional addenda are applicable.

(x) The provision of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated by reference. The following clauses listed in FAR clause 52.212-5 are applicable to the acquisition:

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016)
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)
52.222-36 Equal Opportunity for Workers With Disabilities (Jul 2014)
52.222-50 Combating Trafficking in Persons (Mar 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)

In addition, the following FAR provisions are applicable to this solicitation and incorporated by reference: 52.204-7 System for Award Management (Oct 2018), 52.204-13 System for Award Management Maintenance (Oct 2018), 52.204-16 Commercial and Government Entity Code Reporting (Jul 2016), 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016).

(xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) 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. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria and a price proposal.

Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror's cover sheet.

In addition 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."

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 solicitation number identified in this announcement. Responses must be submitted electronically to [email protected]. Facsimile responses will not be accepted. For information regarding this solicitation, contact Mr. Hunter Tjugum by email at [email protected] or by phone at 301-827-5304.