Attachment 3 - Additional Terms and Conditions.pdf

RFQ No. 775N95022Q00393 Title: Pharmaceutics Formulation/CMC Consulting... for Small Molecules and/or Biologics

Attachment 3. Additional Terms and Conditions

ADDITIONAL TERMS AND CONDITIONS

The following Federal Acquisition Regulations (FAR) clauses and provisions shall apply to this solicitation and all resulting contracts/orders and are included herein by reference:

1. FAR provision 52.212-1 Instructions to Offerors- Commercial Products and Commercial Services (Nov 2021)

2. FAR clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services Alternate I (Nov 2021)

3. FAR clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Mar 2022)

4. The Contractor shall comply with the following FAR provisions that the Contracting Officer has indicated as being incorporated by reference in the contract, to implement provisions of law or Executive orders applicable to acquisitions of commercial services:

- 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017)

- 52.204-7, System for Award Management (Oct 2018)

- 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

- 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-

Representation (Nov 2015)

- 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements-Commercial

Acquisition (Nov 2021)

- 52.217-5, Evaluation of Options (Jul 1990)

5. The Contractor shall comply with the following FAR clauses that the Contracting Officer has indicated as being incorporated by reference in the contract, to implement provisions of law or Executive orders applicable to acquisitions of commercial services:

- 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

- 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021)

- 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)

- 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020)

- 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun

2020)

- 52.204-13, System for Award Management Maintenance. (Oct 2018)

- 52.204-14, Service Contract Reporting Requirements (Oct 2016)

- 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

- 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment (Nov 2021)

- 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct

2018)

- 52.217-9, Option to Extend the Term of the Contract (Mar 2000)

- 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020)

- 52.219-8, Utilization of Small Business Concerns (Oct 2018)

- 52.219-13, Notice of Set-Aside of Orders (Mar 2020)

Title: Pharmaceutics Formulation/CMC Consulting...

for Small Molecules and/or Biologics

Attachment 3. Additional Terms and Conditions

- 52.219-14, Limitations on Subcontracting (Sep 2021)

- 52.219-28, Post-Award Small Business Program Representation (Sept 2021)

- 52.222-3, Convict Labor (Jun 2003)

- 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022)

- 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

- 52.222-26, Equal Opportunity (Sept 2016)

- 52.222-35, Equal Opportunity for Veterans (Jun 2020)

- 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020)

- 52.222-37, Employment Reports on Veterans (Jun 2020)

- 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec

2010)

- 52.222-50, Combating Trafficking in Persons (Nov 2021)

- 52.222-54, Employment Eligibility Verification (May 2022)

- 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun

2020)

- 52.224-3, Privacy Training (Jan 2017)

- 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021)

- 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct

2018)

- 52.239-1, Privacy or Security Safeguards (Aug 1996)

- 52.222-41, Service Contract Labor Standards (Aug 2018)

- 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

- 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (Aug 2018)

- 52.222-55, Minimum Wages for Under Executive Order 14026 (Jan 2022)

- 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022)

- 52.242-15, Stop-Work Order (AUG 1989)

6. The Contractor shall comply with the following Health and Human Services Acquisition Regulations (HHSAR) clauses that the Contracting Officer has indicated as being incorporated by reference in the contract:

- HHSAR clause 352.203-70, Anti-Lobbying (December 18, 2015)

- HHSAR clause 52.224-71, Confidential Information (December 18, 2015)

- HHSAR clause 52.227-70, Publications and Publicity (December 18, 2015)

- HHSARA clause 352.237-75, Key Personnel (December 18, 2015)

- HHSAR clause 352.231-70, Salary Rate Limitation (December 18, 2015)

(a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an for Small Molecules and/or Biologics

Attachment 3. Additional Terms and Conditions individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds.

(c) The salary rate limitation also applies to individuals under subcontracts.

(d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.

(e) See the salaries and wages pay tables on the Office of Personnel Management website for Federal Executive Schedule salary levels.

(End of clause)

Note: The Salary Rate Limitation for these medicinal chemistry consulting services is at the Executive Schedule Level II Rate – see https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf

7. Contracting Officer’s Representative and Contracting Officer The Contracting Officer's Representative (COR) designated for the contract shall be:

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 the COR designated for the contract.

8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

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.

Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen (14) 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 https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf for Small Molecules and/or Biologics

Attachment 3. Additional Terms and Conditions part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

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

http://www.cpars.gov http://www.cpars.gov/

9. COMMERCIAL PROVISIONS