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Non-GMP Synthesis of Compounds
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75N95023Q00507
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This is a combined synopsis/solicitation from the National Institutes of Health National Institute on Drug Abuse seeking non-GMP synthesis of compounds. It requires vendors to synthesize up to 100 ligands that bind KIAA0203 protein in 2-10 milligram quantities under non-GMP conditions over a one year period of performance. Vendors must provide two full-time scientists and one part-time scientist at 25% effort to update progress. Compounds must have a purity of at least 95% and cannot be highly potent or controlled substances. Vendors will provide the synthesized compounds and a certificate of analysis including NMR, MS, and LC data to the agency. Responses are due by July 17, 2023 and the award will be a firm fixed-price purchase order.

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COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Non-GMP Synthesis of Compounds

RFQ: 75N95023Q00507

(i) This is a combined synopsis/solicitation for a commercial product prepared in accordance with the format in Federal Acquisition Regulation (FAR) 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 75N95023Q00507 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 FAR Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the Simplified Acquisition Threshold (SAT). A fixed-price type of purchase order is contemplated for this requirement.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, dated June 2, 2023.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 541380 Testing Laboratories and Services, and the small business size standard is $16,500,000 or less. This requirement shall be solicited using full and open competitive procedures.

(v) DESCRIPTION The Government requires the following brand name or equal services for synthesizing ligands that bind KIAA0203 Please refer to Attachment 1 – Statement of Work for a detailed description of the services description and requirements.

(vi) Please refer to Attachment 1 – Statement of Work for details and information describing the brand name or equal salient characteristics and requirements.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition. The Contractor will perform experiments to synthesize up to 100 compounds in 2-10 milligram quantities under non-GMP conditions. To this end, the Contractor will provide two (2) full-time equivalent (FTE) scientists and one (1) FTE at 25% effort dedicated to the project that can provide updates on its progress over the course of 12 months. Compounds will not be highly potent or controlled substances and have a purity of >95%.

The Contractor shall provide up to 100 compounds in 2-10 milligrams to the Government.

A Standard Certificate of Analysis will be provided for each compound and include 1H nuclear magnetic resonance, mass spectrometry, and liquid chromatography trace.

(viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (MAR 2023) is applicable and incorporated by reference into this solicitation.

(ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. 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.

Each quote will be evaluated in strict conformity with the evaluation factors. 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 solicitation.

The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered.

All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer.

The Government may request clarifying information from the Contractor, as it relates to its quote.

If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable.

The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements.

A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price.

The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes.

1. Technical Capability and Approach

NINDS shall evaluate the offeror’s technical approach for overall capability and functionality in relation to the General Requirement, Approach, Understanding, and Quality Assurance and Deliverables as described in the Statement of Work.

2. Contract Management and Customer Support

NINDS shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of service problems.

Specifically, the Government will evaluate the Offeror’s capability based on its description of it management, customer support, and operational management.

3. Speed of Delivery

NINDS shall evaluate the offeror’s technical proposal for completeness, feasibility, soundness and practicality of the proposed approach and work plan for accomplishing the requirements and timelines identified in the Statement of Work.

PAST PERFORMANCE

The Offeror should provide past performance information. Past performance information Should cover a minimum of one (1) year in relevant services and deliveries of comparable systems. The Offeror Should provide at least one reference for any project identified under the experience factor that has a performance period within the past three (3) years. For each reference, the offeror should provide the following: (1) Organization or contracting partner's name; (2) Point of contact's (POCs) name and contact information (i.e., current phone numbers and valid email addresses); and (3) a description that precisely explains the general scope and specific requirements of the contract.

Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

Furthermore, the Government will assess the relative risks associated with each offeror.

Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information.

PRICE EVALUATION

Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

(x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (DEC 2022), is applicable and incorporated by reference into this solicitation.

(xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (DEC 2022), applies to this acquisition. See Attachment 2.

(xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to

Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023), applies to this acquisition. See Attachment 3.

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

(xiv) The Defense Priorities and Allocations System (DPAS) is 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. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation.

Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; trade-in considerations; warranty considerations; maintenance and service coverage availability;

serial, product or catalog number(s); product description; delivery terms, and prompt payment discount terms.

The Contractor should submit its quote electronically.

Offerors MUST verify 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 vendor Unique Entity Identifier (UEI) 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 July 17, 2023, 11:00 AM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95023Q00507. Responses must be submitted electronically to the Contract Specialist, Alexander Beraud at alexander.beraud@nih.gov with a copy also to the Contracting Officer, Josh Lazarus, at josh.lazarus@nih.gov. For information regarding this solicitation, please contact Alexander Beraud at alexander.beraud@nih.gov.

(xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contract Specialist, Alexander Beraud at alexander.beraud@nih.gov on or before 1:00 PM EST, July 14, 2023. Fax responses will NOT be accepted.

ATTACHMENTS

- Attachment 1 – Staement of Work

- Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (DEC 2022)

- Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023)

- Attachment 4 – Invoice and Payment Instructions

Attachment 2

FAR CLAUSE 52.212-4

CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (OCTOBER 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights --

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C.3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71,Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Non-GMP Synthesis of Compounds

Statement of Need and Purpose:

The Government needs to contract with a full-service facility and staff to support a medicinal chemistry discovery program in developing a novel therapeutic effective in treatment dementias.

Our drug discovery approach will be to synthesize novel ligands based on the high-throughput screen hits that bind our protein of interest, KIAA0203. The results of the efforts of this work will be the basis to advance preclinical candidate compounds for further development.

Background Information and Objective:

The goal of the project is to identify molecules that bind KIAA0203 protein. The Government has kinetic validated structures that bind KIAA0203 to identify protein ligands. The Government now seeks to identify a service for synthesizing ligands that bind KIAA0203.

Period of Performance:

Period of performance of one year (12 months) from July 2023- July 2024.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall 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 below.

Specific Requirements:

The Contractor will perform experiments to synthesize up to 100 compounds in 2-10 milligram quantities under non-GMP conditions. To this end, the Contractor will provide two (2) full-time equivalent (FTE) scientists and one (1) FTE at 25% effort dedicated to the project that can provide updates on its progress over the course of 12 months. Compounds will not be highly potent or controlled substances and have a purity of >95%.

The scope of this project shall be discovery chemistry, computational chemistry/Computer Aided Drug Discovery (CADD) and biology in support of preclinical drug discovery efforts including project planning; project management; design, procurement, and milligram-scale synthesis of chemical analogs, using CADD where appropriate; multi-gram and scale-up synthesis for testing in animal models; in vitro ADME and toxicology testing for lead optimization; and communication.

Purity of compounds shall be >95%

Standard Certificate of Analysis shall be provided for each compound and include: 1H NMR, MS, and LC trace.

The Government shall own Government IP that is provided to and all final products, data, results, information, analyses (collectively "Deliverables") that are generated by the Contractor's employees, agents, contractors, consultants, or other representatives (collectively, "Personnel") in the course of performing the Scope of Work (the "Results"). The Results will be deemed to be Customer Information (as defined below). Excluding Contractor IP, the Government shall own all intellectual property developed in the performance of the Scope of Work. "Government IP" means all intellectual property, processes, know-how, methodologies, technologies, inventions (whether patentable or not), and other proprietary information owned, acquired, developed, or licensed by the Government as of the date of commencement of this Agreement or acquired, developed, or licensed by Government thereafter independently from the Contractor's performance of the Scope of Work.Contractor may retain one copy of the Deliverables that are generated in performance of the Scope of Work. "Contractor IP" means (i) all intellectual property, processes, know-how, methodologies, technologies, inventions (whether patentable or not), and other proprietary information owned, acquired, developed, or licensed by Contractor as of the date of commencement of this Agreement or acquired, developed, or licensed by Contractor thereafter independently from the performance of the Scope of Work ("Contractor Background IP") and (ii) all improvements or modifications made to any Contractor Background IP during the course of performing the Scope of Work that are of general applicability to Contractor's service offerings as a contract research, development and manufacturing organization . Contractor has, and shall retain, sole and exclusive rights of ownership in and to Contractor IP, and the Government does not acquire any license or other rights to Contractor IP except as follows: Contractor hereby grants to the Government a non-exclusive, worldwide, fully paid-up, sublicensable, irrevocable, perpetual license to use the Contractor IP to the extent embedded in a Deliverable solely as necessary to make or have made, use or have used, or sell or have sold the Deliverable. (a) For the term of this Agreement and for five (5) years thereafter, the Contractor shall treat all information of a confidential or proprietary nature received from the Government, including Government IP, and the Results ("Customer Information") as confidential. The Contractor shall not use Customer Information except for the purpose of the Scope of Work and shall not disclose any Customer Information to any third party or personnel except for those Personnel of Contractor who require access thereto to perform the Scope of Work and who are bound by non-use and non-disclosure obligations as stringent as those provided herein. Contractor shall take reasonable steps, including, but not limited to, those steps taken to protect information and other property of its own of a confidential nature, to ensure that the Customer Information are not disclosed, duplicated or in any manner delivered or disseminated to others, unless otherwise expressly permitted by the Government, including this Section. (b) Notwithstanding the foregoing, neither party shall have any of the foregoing obligations of non-use and non-disclosure with respect to information disclosed hereunder that (i) is or becomes publicly known and made generally available through no fault or action of the receiving party; (ii) was in the receiving party's possession without obligation of confidentiality at the time of disclosure by the other party; (iii) is independently developed by the receiving party as established by competent written evidence;

or (iv) is received by the receiving party from a third party without an accompanying duty of confidentiality, and as established by competent contemporaneous written evidence for each of

(i) through (iv). (c) In the event the receiving party becomes legally compelled to disclose any Information of the disclosing party, the receiving party shall: (i) provide the disclosing party with prompt notice so that the disclosing party may, in its sole discretion and with reasonable cooperation of the receiving party, seek a protective order or other appropriate remedy; and (ii) if such protective order or other appropriate remedy is not obtained, furnish only that portion of the Information which the receiving party is legally required to disclose. (d) Upon the expiration or termination of this Agreement, each party shall cease using the other party's Information and, upon the written request of the disclosing party, and at the disclosing party's option, the other party shall return or destroy (and certify as having been destroyed) all written or other physical embodiments of such Information, together with all full or partial copies, extracts, and summaries thereof, as are then in the party's possession or control; provided, however, that each party may retain one (1) complete record copy of the disclosing party's Information solely for archival purposes to assure compliance with this Agreement; provided that the same Information so retained retains its confidential protection as set forth in this Section 4.

LEVEL OF EFFORT:

Vendor staff will provide the results via reporting transfer through email.

GOVERNMENT RESPONSIBILITIES

The government will provide structural information on hit compounds identified.

DELIVERY OR DELIVERABLES

The Contractor shall provide up to 100 compounds in 2-10 milligrams to the Government. A Standard Certificate of Analysis will be provided for each compound and include 1H nuclear magnetic resonance, mass spectrometry, and liquid chromatography trace

REPORTING REQUIREMENTS

The Vendor shall provide a progress report monthly during the contract period through email.

The progress report shall include the number of compounds that have been synthesized and timelines for when future compounds are anticipated. This report shall include a description of any problems encountered and whether these issues were resolved.

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the vendor’s work site. Travel for contractor employees will not be necessary.

Key Personnel:

Vendor will provide two (2) FTEs to the government as point of contacts for the services.

Information System Security Plan:

Not Applicable

Data Rights:

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Confidentiality of Information:

any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include --

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer— System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period at fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law.

If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause.

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) Reserved

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End Use License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

Alternate I (Jan 2017) When a time-and-materials or labor-hour contract is contemplated, substitute the following paragraphs (a), (e), (i), (l), and (m) for those in the basic clause.

(a) Inspection/Acceptance.

(1) The Government has the right to inspect and test all materials furnished and services performed under this contract, to the extent practicable at all places and times, including the period of performance, and in any event before acceptance. The Government may also inspect the plant or plants of the Contractor or any subcontractor engaged in contract performance. The Government will perform inspections and tests in a manner that will not unduly delay the work.

(2) If the Government performs inspection or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish and shall require subcontractors to furnish all reasonable facilities and assistance for the safe and convenient performance of these duties.

(3) Unless otherwise specified in the contract, the Government will accept or reject services and materials at the place of delivery as promptly as practicable after delivery, and they will be presumed accepted 60 days after the date of delivery, unless accepted earlier.

(4) At any time during contract performance, but not later than 6 months (or such other time as may be specified in the contract) after acceptance of the services or materials last delivered under this contract, the Government may require the Contractor to replace or correct services or materials that at time of delivery failed to meet contract requirements.

Except as otherwise specified in paragraph (a)(6) of this clause, the cost of replacement or correction shall be determined under paragraph (i) of this clause, but the “hourly rate” for labor hours incurred in the replacement or correction shall be reduced to exclude that portion of the rate attributable to profit. Unless otherwise specified below, the portion of the “hourly rate” attributable to profit shall be 10 percent. The Contractor shall not tender for acceptance materials and services required to be replaced or corrected without disclosing the former requirement for replacement or correction, and, when required, shall disclose the corrective action taken. [Insert portion of labor rate attributable to profit.]

(5) (5)

(i) If the Contractor fails to proceed with reasonable promptness to perform required replacement or correction, and if the replacement or correction can be performed within the ceiling price (or the ceiling price as increased by the Government), the Government may—

(A) By contract or otherwise, perform the replacement or correction, charge to the Contractor any increased cost, or deduct such increased cost from any amounts paid or due under this contract; or

(B) Terminate this contract for cause.

(ii) Failure to agree to the amount of increased cost to be charged to the Contractor shall be a dispute under the Disputes clause of the contract.

(6) Notwithstanding paragraphs (a)(4) and (5) above, the Government may at any time require the Contractor to remedy by correction or replacement, without cost to the Government, any failure by the Contractor to comply with the requirements of this contract, if the failure is due to--

(i) Fraud, lack of good faith, or willful misconduct on the part of the Contractor’s managerial personnel; or

(ii) The conduct of one or more of the Contractor’s employees selected or retained by the Contractor after any of the Contractor’s managerial personnel has reasonable grounds to believe that the employee is habitually careless or unqualified.

(7) This clause applies in the same manner and to the same extent to corrected or replacement materials or services as to materials and services originally delivered under this contract.

(8) The Contractor has no obligation or liability under this contract to correct or replace materials and services that at time of delivery do not meet contract requirements, except as provided in this clause or as may be otherwise specified in the contract.

(9) Unless otherwise specified in the contract, the Contractor’s obligation to correct or replace Government-furnished property shall be governed by the clause pertaining to Government property.

(e) Definitions.

(1) The clause at FAR 52.202-1, Definitions, is incorporated herein by reference. As used in this clause—

(i) Direct materials means those materials that enter directly into the end product, or that are used or consumed directly in connection with the furnishing of the end product or service.

(ii) Hourly rate means the rate(s) prescribed in the contract for payment for labor that meets the labor category qualifications of a labor category specified in the contract that are—

(A) Performed by the contractor;

(B) Performed by the subcontractors; or

(C) Transferred between divisions, subsidiaries, or affiliates of the contractor under a common control.

(iii) Materials means—

(A) Direct materials, including supplies transferred between divisions, subsidiaries, or affiliates of the contractor under a common control;

(B) Subcontracts for supplies and incidental services for which there is not a labor category specified in the contract;

(C) Other direct costs (e.g., incidental services for which there is not a labor category specified in the contract, travel, computer usage charges, etc.);

(D) The following subcontracts for services which are specifically excluded from the hourly rate: [Insert any subcontracts for services to be excluded from the hourly rates prescribed in the schedule.]; and

(E) Indirect costs specifically provided for in this clause.

(iv) Subcontract means any contract, as defined in FAR Subpart 2.1, entered into with a subcontractor to furnish supplies or services for performance of the prime contractor a subcontract including transfers between divisions, subsidiaries, or affiliates of a contractor or subcontractor. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

(i) Payments.

(1) Work performed. The Government will pay the Contractor as follows upon the submission of commercial invoices approved by the Contracting Officer:

(i) Hourly rate.

(A) The amounts shall be computed by multiplying the appropriate hourly rates prescribed in the contract by the number of direct labor hours performed. Fractional parts of an hour shall be payable on a prorated basis.

(B) The rates shall be paid for all labor performed on the contract that meets the labor qualifications specified in the contract. Labor hours incurred to perform tasks for which labor qualifications were specified in the contract will not be paid to the extent the work is performed by individuals that do not meet the qualifications specified in the contract, unless specifically authorized by the Contracting Officer.

(C) Invoices may be submitted once each month (or at more frequent intervals, if approved by the Contracting Officer) to the Contracting Officer or the authorized representative.

(D) When requested by the Contracting Officer or the authorized representative, the Contractor shall substantiate invoices (including any subcontractor hours reimbursed at the hourly rate in the schedule) by evidence of actual payment, individual daily job timecards, records that verify the employees meet the qualifications for the labor categories specified in the contract, or other substantiation specified in the contract.

(E) Unless the Schedule prescribes otherwise, the hourly rates in the Schedule shall not be varied by virtue of the Contractor having performed work on an overtime basis.

(1) If no overtime rates are provided in the Schedule and the Contracting Officer approves overtime work in advance, overtime rates shall be negotiated.

(2) Failure to agree upon these overtime rates shall be treated as a dispute under the Disputes clause of this contract.

(3) If the Schedule provided rates for overtime, the premium portion of those rates will be reimbursable only to the extent the overtime is approved by the Contracting Officer.

(ii) Materials.

(A) If the Contractor furnishes materials that meet the definition of a commercial item at FAR 2.101, the price to be paid for such materials shall not exceed the Contractor’s established catalog or market price, adjusted to reflect the--

(1) Quantities being acquired; and

(2) Any modifications necessary because of contract requirements.

(B) Except as provided for in paragraph (i)(1)(ii)(A) and (D)(2) of this clause, the Government will reimburse the Contractor the actual cost of materials (less any rebates, refunds, or discounts received by the contractor that are identifiable to the contract) provided the Contractor—

(1) Has made payments for materials in accordance with the terms and conditions of the agreement or invoice; or

(2) Makes these payments within 30 days of the submission of the Contractor’s payment request to the Government and such payment is in accordance with the terms and conditions of the agreement or invoice.

(C) To the extent able, the Contractor shall—

(1) Obtain materials at the most advantageous prices available with due regard to securing prompt delivery of satisfactory materials; and

(2) Give credit to the Government for cash and trade discounts, rebates, scrap, commissions, and other amounts that are identifiable to the contract.

(D) Other Costs. Unless listed below, other direct and indirect costs will not be reimbursed.

(1) Other direct Costs. The Government will reimburse the Contractor on the basis of actual cost for the following, provided such costs comply with the requirements in paragraph (i)(1)(ii)(B) of this clause: [Insert each element of other direct costs (e.g., travel, computer usage charges, etc.

Insert “None” if no reimbursement for other direct costs will be provided.

If this is an indefinite delivery contract, the Contracting Officer may insert “Each order must list separately the elements of other direct charge(s) for that order or, if no reimbursement for other direct costs will be provided, insert ‘None’.”]

(2) Indirect Costs (Material handling, Subcontract Administration, etc.).

The Government will reimburse the Contractor for indirect costs on a pro-rata basis over the period of contract performance at the following fixed price: [Insert a fixed amount for the indirect costs and payment schedule.

Insert “$0” if no fixed price reimbursement for indirect costs will be provided. (If this is an indefinite delivery contract, the Contracting Officer may insert “Each order must list separately the fixed amount for the indirect costs and payment schedule or, if no reimbursement for indirect costs, insert ‘None’.”]

(2) Total cost. It is estimated that the total cost to the Government for the performance of this contract shall not exceed the ceiling price set forth in the Schedule and the Contractor agrees to use its best efforts to perform the work specified in the Schedule and all obligations under this contract within such ceiling price. If at any time the Contractor has reason to believe that the hourly rate payments and material costs that will accrue in performing this contract in the next succeeding 30 days, if added to all other payments and costs previously accrued, will exceed 85 percent of the ceiling price in the Schedule, the Contractor shall notify the Contracting Officer giving a revised estimate of the total price to the Government for performing this contract with supporting reasons and documentation. If at any time during the performance of this contract, the Contractor has reason to believe that the total price to the Government for performing this contract will be substantially greater or less than the then stated ceiling price, the Contractor shall so notify the Contracting Officer, giving a revised estimate of the total price for performing this contract, with supporting reasons and documentation. If at any time during performance of this contract, the Government has reason to believe that the work to be required in performing this contract will be substantially greater or less than the stated ceiling price, the Contracting Officer will so advise the Contractor, giving the then revised estimate of the total amount of effort to be required under the contract.

(3) Ceiling price. The Government will not be obligated to pay the Contractor any amount in excess of the ceiling price in the Schedule, and the Contractor shall not be obligated to continue performance if to do so would exceed the ceiling price set forth in the Schedule, unless and until the Contracting Officer notifies the contractor in writing that the ceiling price has been increased and specifies in the notice a revised ceiling that shall constitute the ceiling price for performance under this contract. When and to the extent that the ceiling price set forth in the Schedule has been increased, any hours expended and material costs incurred by the Contractor in excess of the ceiling price before the increase shall be allowable to the same extent as if the hours expended and material costs had been incurred after the increase in the ceiling price.

(4) Access to records. At any time before final payment under this contract, the Contracting Officer (or authorized representative) will have access to the following (access shall be limited to the listing below unless otherwise agreed to by the Contractor and the Contracting Officer):

(i) Records that verify that the employees whose time has been included in any invoice met the qualifications for the labor categories specified in the contract.

(ii) For labor hours (including any subcontractor hours reimbursed at the hourly rate in the schedule), when timecards are required as substantiation for payment—

(A) The original timecards (paper-based or electronic);

(B) The Contractor’s timekeeping procedures;

(C) Contractor records that show the distribution of labor between jobs or contracts; and

(D) Employees whose time has been included in any invoice for the purpose of verifying that these employees have worked the hours shown on the invoices.

(iii) For material and subcontract costs that are reimbursed on the basis of actual cost—

(A) Any invoices or subcontract agreements substantiating material costs;

and

(B) Any documents supporting payment of those invoices.

(5) Overpayments/Underpayments. Each payment previously made shall be subject to reduction to the extent of amounts, on preceding invoices, that are found by the Contracting Officer not to have been properly payable and shall also be subject to reduction for overpayments or to increase for underpayments. The Contractor shall promptly pay any such reduction within 30 days unless the parties agree otherwise. The Government within 30 days will pay any such increases, unless the parties agree otherwise. The Contractor’s payment will be made by check. If the Contractor becomes aware of a duplicate invoice payment or that the Government has otherwise overpaid on an invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6)(6)

(i) All amounts that become payable by the Contractor to the Government under this contract shall…

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