75N93024R00022- Signed.pdf

SECTION

15A. NAME AND

ADDRESS

OF OFFEROR

SOLICITATION, OFFER, AND AWARD 1. This Contract is a Rated Order under the Defense Priorities and Allocations System (DPAS) - Code of Federal Regulations - at 15 CFR 700.

RATING PAGE

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

CODE7. ISSUED BY 8. ADDRESS OFFER TO (If other than item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in until local time

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision Number 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR

INFORMATION

CALL:

A. NAME B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

C. EMAIL ADDRESS

11. TABLE OF CONTENTS

(X) DESCRIPTION PAGE(S) (X) SECTION PAGE(S)DESCRIPTION

A B

C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause Number 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

DATEAMENDMENT NUMBERAMENDMENT NUMBER DATE

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

AREA CODE NUMBER EXTENSION

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION UNDER THE

UNITED STATES CODE AT:

10 U.S.C. 3204(a) ( )41 U.S.C. 3304(a) (

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 12/2022)

Prescribed by GSA - FAR (48 CFR) 53.214 (c)

SEALED BID (IFB) INVITATION FOR BID

NEGOTIATED (RFP) REQUEST FOR

PROPOSAL

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

15B. TELEPHONE NUMBER

CODE

OF PAGES

75N93024R00022 ignacio.reyes@nih.gov

IGNACIO J. REYES

National Institutes of Health National Institute of Allergy and Infectious Diseases Bethesda, MD 20892-7612

NIAID-ROCK

1630 ED

IGNACIO J REYES

15 50

301 435 7574

1 53

SECTION B - Supplies or Services/Prices

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. PRICES

ARTICLE B.3. OPTION PRICES

SECTION C - Description/Specifications

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging and Marking

SECTION E - Inspection and Acceptance

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

SECTION G - Contract Administration Data

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

ARTICLE G.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

SECTION H - Special Contract Requirements

ARTICLE H.1. HUMAN SUBJECTS

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING

FROM NIH-FUNDED RESEARCH

ARTICLE H.4. DUAL USE RESEARCH OF CONCERN

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

ARTICLE H.7. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

ARTICLE H.8. OMB CLEARANCE

ARTICLE H.9. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.10. GUN CONTROL

ARTICLE H.11. OPTION PROVISION

ARTICLE H.12. SUBCONTRACTING PROVISIONS

ARTICLE H.13. INFORMATION SYSTEM DESIGN AND DEVELOPMENT, HHSAR 352.239-73 (FEB 2024)

(DEVIATION)

ARTICLE H.14. INFORMATION SYSTEM HOSTING, OPERATIONS, MAINTENANCE, OR USE, HHSAR

352.239-74 (FEB 2024) (DEVIATION)

ARTICLE H.15. COMMUNICATIONS MATERIALS AND SERVICES

ARTICLE H.16. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST

ARTICLE H.17. PUBLICATION AND PUBLICITY

ARTICLE H.18. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.19. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

ARTICLE H.20. SHARING RESEARCH DATA

ARTICLE H.21. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

ARTICLE H.22. HIGHLY PATHOGENIC AGENTS

ARTICLE H.23. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.24. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

ARTICLE H.25. CONSTITUTION DAY

ARTICLE H.26. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

ARTICLE H.28. GUIDELINES FOR INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH

DISABILITIES IN NIH-SUPPORTED CONFERENCES

ARTICLE H.29. USE OF FUNDS FOR PROMOTIONAL ITEMS

SECTION I - Contract Clauses

ARTICLE 1. GENERAL CLAUSES

ARTICLE 2. AUTHORIZED SUBSTITUTION OF CLAUSES

ARTICLE 3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

ARTICLE 4. SMALL BUSINESS ADMINISTRATION - 8(a) PROGRAM CLAUSES

ARTICLE 5. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

SECTION L - Instructions, Conditions, and Notices to Bidders

SECTION M - Evaluation Factors for Award

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION. ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A – SOLICITATION , ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO

THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE

INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE TERMS AND

CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - Supplies or Services/Prices

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The aim of this solicitation is to continue the Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB) responsible for coordinating and conducting the design, synthesis, in vitro testing, and distribution of chemical libraries of discrete small-molecules with diverse physicochemical properties, specifically designed to target Gram-negative bacterial pathogens and other antibiotic-resistant bacteria identified as Antimicrobial Resistance threats.

ARTICLE B.2. PRICES

The final contract will contain the price provisions agreed upon by the Government and the Offeror. Please see the excel pricing sheets located under CC4CARB Pricing Sheet (excel file).

ARTICLE B.3. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR Clause 52.217-9/Option to Extend set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The fixed price of this contract will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the [Option Item/Option Items/Option Service/Option Services] described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth on the price sheet provided.

The option(s) are to be priced separately and will be evaluated prior to award. In accordance with FAR 52.217-5, Evaluation of Options, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

SECTION C - Description/Specifications

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 01/02/2025 , attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. All electronic contract deliverables shall be submitted via NIAID electronic Report Deliverable Submission (eRDS) site, available at the following website: https://erds.niaid.nih.gov/. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under “Making Files Accessible.”.

A. Technical Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods.

The frequency and specific content of these reports will be determined prior to contract award. The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

NOTE: For proposal preparation purposes only, it is estimated that the following reports will be required in electronic format:

1. Meeting Agenda and Minutes

The Contractor shall email the agenda of each planned meeting with NIAID to all NIAID participants one (1) business day in advance of the meeting. The Contractor shall submit minutes and presentation materials within three (3) business days of each meeting. Minutes must include date, time, and https://erds.niaid.nih.gov/ http://www.hhs.gov/web/508/index.html location of the meeting, attendance, details of all discussion including questions asked and answers, and action items.

2. Individual Library Production Plan (ILPP)

The Contractor shall generate an ILPP for each Library Design. The ILPP describes the overall project plan to produce a library of approximately 80 compounds derived from a novel chemical scaffold or otherwise representative of novel chemical space for antibacterial agents. The ILPP should be designated as either low complexity or high complexity per the definitions provided (see Attachment 1 - SOW). An ILPP may propose more or fewer than 80 compounds to allow for unanticipated chemistry failures or chemistry anticipated to have greater risk of failure, particularly in the case of high complexity libraries. An ILPP may propose rules for ad-hoc addition of unspecified compounds without prior COR approval. No more than 40 additional compounds may be added using ad-hoc rules and no more than 120 compounds total may be tested or invoiced per ILPP without concurrence of the COR. The ILPP will be reviewed by the COR prior to initiation of chemical synthesis, which may not commence without written concurrence of the COR. The date of COR concurrence will establish the embargo period (see Attachment 1 - SOW) start date for all compounds in the ILPP, including any compounds added (via ad-hoc rules) at a later date. The Contractor is encouraged, but not required, to discuss the ILPP plan with the COR in advance of requesting concurrence of an ILPP. An ILPP may not be amended once it has been concurred by the COR. Rather, in the event a significant technical revision is required, the Contractor shall close the ILPP and create a new one containing the necessary revisions. The Contractor shall include the following in each ILPP:

A brief summary of the rationale and background information A designation of whether the ILPP is low or high complexity A structure of the core scaffold and scheme(s) for elaboration into the proposed library A table of targeted products with calculated physicochemical properties for each product Synthetic routes with relevant supporting literature references A timeline and/or Gantt chart of key activities Optional ad-hoc rules: A framework of rules for defining additional ad-hoc products should they be needed to complete the ILPP. Including this framework allows the Contractor to synthesize additional products that were not initially proposed, without advance COR concurrence, but which support the goals of the ILPP.

An ILPP is complete when one of the following criteria is met: (1) The maximum number of target compounds in the ILPP have been completed, or the Contractor has determined no additional compounds can be completed for any reason; (2) the COR determines the ILPP is complete and communicates the determination to the Contractor in writing; or (3) the current term of the contract expires. If a continuing term option has been awarded, the Contractor may roll-over some or all targets from a previous ILPP into a new ILPP for the new contract term. An ILPP concurred by the COR in one performance period may not continue into the next performance period. This is to allow the Contractor to invoice a partially completed ILPP to the performance period in which the work was done. Otherwise, all delivered compounds are invoiced to the performance period in which the ILPP was completed regardless of when work on the ILPP compounds started.

In all cases, a completed ILPP may only be invoiced after the COR has accepted an Individual Library Production Plan Report (ILPP-R) for the ILPP.

3. Individual Library Production Plan Report (ILPP-R)

The Contractor shall submit an ILPP Report (ILPP-R) within 30 days of the date the ILPP was completed, unless notified otherwise by the COR. An ILPP-R must be submitted and accepted by the COR before compounds produced under the ILPP may be invoiced by the Contractor. This report describes the results achieved during production of the ILPP. The report should include a status for each proposed target in a table including, at minimum, whether the target was attempted, succeeded (or failed), and what quantity of each storage form (solid, liquid) is now available.

Technical problems encountered should be included along with a brief discussion of resolutions. If an outside collaborator was involved, discussion of the impact on the collaborator’s program should be included. An ILPP-R submission must be accompanied by special appendices provided as separate electronic files as detailed below:

Appendix A. Experimental Procedures – A document containing text experimental procedures for all compounds in a format acceptable for publication in a common high impact chemistry journal (such as Journal of American Chemical Society). Generalized procedures may be provided where the same reaction was performed multiple times, varying only reactants employed. Graphical spectra supporting experimental conclusions must be provided for key intermediates and all final compounds.

4. Singleton Synthesis Report (SSR)

The Contractor shall submit a Singleton Synthesis Report (SSR) within 30 days of completion of a singleton synthesis requested by the COR. An SSR must be submitted and accepted by the COR before a singleton synthesis may be invoiced by the Contractor. The report may include more than one singleton synthesis provided the reported syntheses are related by either deriving from the same ILPP or using substantially the same synthetic route. This report includes a reference to the ILPP from which the singleton was derived and describes the results achieved during production of the singleton. Technical problems encountered should be included along with a brief discussion of resolutions. An SSR submission must include experimental procedures specific to the singleton synthesis undertaken, including text experimental procedures in a format acceptable for publication in a common high impact chemistry journal (such as Journal of American Chemical Society) and graphical spectra supporting experimental conclusions must be provided for key intermediates and the final compound.

5. Compound Testing Report (CTR)

The Contractor shall submit a Compound Testing Report (SSR) within 15 calendar days of completion of an MIC panel run. A CTR must be submitted and accepted by the COR before invoicing for the corresponding MICs by the Contractor. This report includes a reference to the ILPP(s) from which the tested compounds derived and describes the results achieved during the MIC testing. At minimum, the report should include a general description of the panel organisms and testing protocol and a table of MIC results in ug/mL units for each compound against each panel organism.

Technical problems encountered should be included along with a brief discussion of resolutions. If a subcontractor performed the MICs, the subcontractor final report may be submitted in lieu of a CTR, provided it includes the required information.

6. Monthly Progress Report

The contractor shall submit a Monthly Progress Report by the 15th of each month following the reporting period, except as noted. The first Monthly Progress Report is due on the 15th of the second full month of the contract, covering a performance period from the contract award date to the end of the first full month of the contract. Thereafter, the reporting period is each calendar month. In a month when the Annual Progress Report is due, the Monthly Progress Report is not due, however, the content of that month’s performance should be incorporated into the Annual Progress Report.

The Monthly Progress Report should be concise and will include a description of the activities during the reporting period organized into the following sections:

Title Page Executive Summary Library Ideas in Development Active ILPP Status Compound Testing Compound Management

7. Annual Progress Report

The Contractor shall submit an Annual Progress Report by the 15th of the month following the end of the reporting period. The Annual Progress Report provides a summation of the results of one performance year. The format of the Annual Progress Report must closely follow the format established for the Monthly Progress Report except covering the scope of one performance year and including a section reporting the results of monitoring the integrity of the compound collection.

The Annual Progress Report shall include the following sections:

Title Page Executive Summary Library Ideas in Development Completed ILPPs Compound Testing Compound Management Compound Collection Integrity

The Annual Report submission must be accompanied by an appendix provided as a separate electronic file as described below:

Appendix A. Compound Table - An Excel table containing one row for each completed compound and columns reporting compound structure (ie SMILES), MIC data, compound inventory information, physicochemical properties, and other relevant per compound data.

8. Final Report

The Contractor shall submit a final report by the last day of the contract. The Contractor shall complete the Annual Report for the final contract year before completing the Final Report. The Final Report must then collate the Annual reports as follows:

Title Page Executive Summary Full budget Summary Annual Report Year 1 Annual Report Years 2 - 8, if exercised.

The Final Report submission must be accompanied by an appendix provided as a separate electronic file as described below:

Appendix A. Compound Table - An Excel table containing one row for each completed compound and columns reporting compound testing data, compound inventory information, physicochemical properties, and other relevant per compound data in the same format as provided for the Annual Report Compound Table.

B. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in [Electronic/Hard Copy] format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual _report.doc.

3. REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website: https://erds.niaid.nih.gov/ . All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section- 508/index.html and at: https://www.section508.gov/create/documents , 'Create Accessible Documents.'

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government] including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. Thereafter, reports shall be due on or before the 15th Calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the COR and CO identified in the awarded contract via email.

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - Packaging and Marking

A. PACKAGING, MARKING, AND SHIPPING

Not Required.

http://www.iedison.gov/ http://www.iedison.gov/

SECTION E - Inspection and Acceptance

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, MSC 9821 Bethesda, MD 20892-9821

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-2, Inspection of Supplies - Fixed Price (August 1996).

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-7, Inspection of Research and Development - Fixed Price (August 1996).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The anticipated period of performance of the base period of this contract is February 1, 2027 through January 31, 2028.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Term Option Period A-1 February 1, 2028 through January 31, 2029

Term Option Period A-2 February 1, 2029 through January 31, 2030

Term Option Period A-3 February 1, 2030 through January 31, 2031

Term Option Period A-4 February 1, 2031 through January 31, 2032

Term Option Period A-5 February 1, 2032 through January 31, 2033

Term Option Period A-6 February 1, 2033 through January 31, 2034

Term Option Period A-7 February 1, 2034 through January 31, 2035

Quantity Options shall run concurrently with the contract period in which they are exercised. Quantity Options shall not exceed the period of performance of the contract period in which they are exercised.

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984) is not applicable to this contract.

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

52.242-17, Government Delay of Work (April 1984).

SECTION G - Contract Administration Data

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

https://www.acquisition.gov/?q=browsefar

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is

NIAID, NIH.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request.

The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer.

Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and https://www.ipp.gov/ address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: Chemistry Center for Combating Antibiotic-Resistant Bacteria

(CC4CARB)

3. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

“I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract.”

ARTICLE G.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually at 12-month intervals after award.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

a. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://www.cpars.gov.

End of clause.

SECTION H - Special Contract Requirements

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at https://grants.nih.gov/policy/reproducibility/index.htm, including FAQs and a General Policy Overview.

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING

FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from any NIH-funded or conducted research, supported in whole or in part with direct costs from NIH regardless of NIH funding mechanism. NIH defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications that result from the publishing and peer review process, and which should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the award/support period, whichever comes first. The PMC archive will permanently preserve and retain these manuscripts for use by the public, health care providers, educators, scientists, and NIH. NIH Policy directs electronic submissions to the NIH/NLM/PMC: https://www.ncbi.nlm.nih.gov/pmc/.

Additional information is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html and https://publicaccess.nih.gov/.

ARTICLE H.4. DUAL USE RESEARCH OF CONCERN

The Contractor shall comply with the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern ( https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf ) or "DURC policy". The responsibilities of the Contractor include but are not limited to:

1. Establishing internal policies and practices that provide for the identification and effective oversight of

DURC;

2. Establishing an institutional review entity (IRE);

3. Ensuring that laboratory personnel conducting research have received education and training;

4. Maintaining records of institutional DURC reviews and completed risk mitigation plans related to research conducted under this contract, for the term of the contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation;

5. Promptly providing records upon request by the U.S. Government, of institutional DURC reviews and completed risk mitigation plans related to research conducted under this contract;

6. Obtaining pre-approval from the Contracting Officer's Representative for all communications with third-parties, involving DURC funded by this contract, and;

7. Obtaining pre-approval from the Contracting Officer for subcontracts, subgrants, consultant agreements, or any other subaward involving research subject to the DURC policy and funded by this contract. The contractor shall ensure that the substantive requirements of this article are included in any such agreements.

Non-compliance with the DURC policy or with this article may result in suspension, debarment or termination for default.

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.7. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act)(5 U.S.C. 552a(m)(1)) and applicable agency regulations.

The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in CFR 45 part 5band that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s)of records [5 U.S.C. 552a(m)(1)]. The contract work statement:

(a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and

(b) specifies the disposition to be made of such records upon completion of contract performance.

ARTICLE H.8. OMB CLEARANCE

In accordance with HHSAR 352.211-3, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer Representative (COR) and the Contracting Officer has issued written approval to proceed.

ARTICLE H.9. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.10. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.11. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.

Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item /FAR Clause 52.217- 9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given before the expiration date of this contract, and the price of the contract will be increased as set forth in the OPTION PRICES Article in SECTION B of this contract.

ARTICLE H.12. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror( s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled " Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages- Subcontracting Plan."

b. Subcontracting Reports

1. An offeror is to submit their respective subcontracting plan electronically using the U.S.

Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov . The offeror shall follow the instructions outlined in the SBCX Industry Guide at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

2. The official point of receipt for determining timely submission of an offeror's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

3. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late in accordance with subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offeror-Competition Acquisition. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday - Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the presented client support hours of operation for assistance.

5. Individual Subcontract Reports ( ISR)

The Contractor must submit the following Subcontracting reports electronically via the Subcontracting Reporting System (eSRS) at https://www.esrs.gov/.

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

6. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report must be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the [Contracting Officer/Contract Specialist/title of alternate designee] must be included as a contact for notification purposes at the following e- mail address:

Ignacio J. Reyes Contracting Officer

ARTICLE H.13. INFORMATION SYSTEM DESIGN AND DEVELOPMENT, HHSAR 352.239-73 (FEB 2024)

(DEVIATION)

(a) Design or development at non-HHS facilities. Information systems that are designed or developed for or on behalf of HHS at non-HHS facilities shall comply with all HHS directives developed in accordance with the Federal Information Security Modernization Act of 2014, Health Insurance Portability and Accountability Act (HIPAA) regulations, National Institute of Standards and Technology (NIST), and related HHS security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic protected health information (PHI), outlined in 45 CFR Part 164, Subpart C, information and system security categorization level designations in accordance with Federal Information Processing Standards (FIPS) 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization and the Trusted Internet Connections Reference Architecture.

(b) Privacy Impact Assessment. During the development cycle a Privacy Impact Assessment must be completed by the contractor, provided to the Contracting Officer Representative, and approved by the appropriate HHS and Operating Division security and privacy officials; government, contractor, or independent third party.

(c) Security of procured or developed systems and technologies. The Contractor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of the contract and any extension, warranty, or maintenance periods.