F_CSS_NonComp Posting.doc

Exhibit 11

NON-COMPETITIVE

SEQ CHAPTER \h \r 1COMBINED SYNOPSIS / SOLICITATION

Title:

Testing of compounds for inhibition of CYP enzymes (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 75N95020Q00305 and the solicitation is issued as a request for quotation (RFQ).

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; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), NIDA Office of Acquisitions – National Center for Advancing Translational Sciences (NCATS) Section, on behalf of the NCATS intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Cyprotex US LLC.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-07, dated 08/03/2020.

(iv) The associated NAICS code 541990 and the small business size standard is $16.5M. This requirement has no set-aside restrictions.

(v) Project requirements:

The Lab requires contractor support for laboratory testing services. Services are broken down into three parts, as described below.

Part 1: This part provides for testing of 30 small molecule compounds for inhibition of the CYP enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase program. Testing of the compounds for their capacity to inhibit the full CYP enzyme panel will help to identify their propensity for creating drug-drug interactions, and alert us to any such issues that would need to be solved in order for drug candidates to advance into human clinical testing.

Part 2: This part provides for testing of 30 small molecule compounds for stability in mouse, rat, dog, cyno monkey, and human liver microsomes. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase program. Testing of the compounds for their stability in microsomes will provide critical information on their clearance properties, and will inform subsequent in vivo pharmacokinetic studies in various species.

Part 3: This part provides for testing of 30 small molecule compounds for permeability in Caco-2 cells. These compounds are drug molecules being evaluated for the dual IRAK4-FLT3 kinase program. Testing of the compounds for permeability and active transport in Caco-2 cells will provide critical information on their transport properties, and will allow us to prioritize the development of compounds with optimal transport properties.

In conjunction with the Lab’s external partner, Cincinnati Children’s Hospital, the Lab has an ongoing program aimed at developing inhibitors of these enzymes, and have tested previous compounds in this series for inhibition of CYP enzymes using Cyprotex’s assays. The Lab is synthesizing additional compounds in this series in order to further optimize their properties, and need to employ the same assay platform (Cyprotex’s CYP inhibition assays) that was used to generate the original data in order to maintain continuity of service and allow a direct, apples-to-apples comparison of newly generated and previously generated data. The use of another vendor, or any other break in scientific continuity, could invalidate years of data collected. Cyprotex has previously provided this testing service for our project under purchase orders 75N95019P00369, 75N95019P00370, and 75N95020P00056.

(vi) Delivery Location:

The National Center for Advancing Translational Sciences (NCATS)

9800 Medical Center Drive

Rockville, MD 20850

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(viii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition.

(a) 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.

(b) Offers will be evaluated for technical criteria, price, and past performance. Technical criteria consists of matching the line item identified above. Technical and past performance, when combined, are significantly more important than price.

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer.

(x) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

The following FAR provisions or clauses are 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 Entity Code Reporting (Jul 2016)

52.204-18, Commercial and Entity Code Maintenance (Jul 2016)

52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services of Equipment

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015).

52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions (2/2014).

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition (xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) The offeror must complete and return FAR 52.204-24 with its offer.

(xiv) 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 that believe that they are manufacturers or authorized resellers 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.

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 by September 8, 2020, 9:00 am, Eastern Standard Time and reference number 75N95020Q00305. Responses shall be submitted electronically to Kevin Alvarez, Contracting Officer, kevin.alvarez@nih.gov.

Fax responses will not be accepted.

(xv) The name of the individual to contact for information regarding the solicitation:

Kevin Alvarez, Contracting Officer, kevin.alvarez@nih.gov.