19-FDA-SOL-1210258.pdf

COMBINED SYNOPSIS/SOLICITATION FOR gSOLIDS Licenses

SOLICITATION NUMBER: 19-FDA-SOL-1210258

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The Food and Drug Administration intends to award a sole source firm-fixed price purchase order to Process Systems Enterprise Inc., 3 Wing Dr. STE 103, Cedar Knolls, NJ, 07927-1002 in accordance with FAR part 13.106-1(b)(1)(i). This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13.

ii. The solicitation number is 19-FDA-SOL-1210258.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2019-01, Effective 22 Jan 2019

iv. The associated North American Industry Classification System (NAICS) Code is 541512 Computer Systems Design Services; Small Business Size Standard is $27.5 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes with:

a) Pricing for all line items

b) If re-seller, must submit authorized letter from Original Equipment Manufacturer (OEM).

c) Accessibility Conformance Report (ACR) Quotes that do not price all line items may be deemed non-responsive.

Period for Acceptance of Offers: The offeror agrees to hold the prices firm for 30 calendar days after quote due date.

Line Item

Description Qty Unit Unit Price Total Line Price

1 BASE PERIOD

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise;

Current Product License Number PSE-CSW-I-US-20180709)

1 EA $ $

2 OPTION PERIOD ONE (1)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise;

Current Product License Number PSE-CSW-I-US-20180709)

1 EA $ $

3 OPTION PERIOD TWO (2)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise;

Current Product License Number PSE-CSW-I-US-20180709)

1 EA $ $

4 OPTION PERIOD THREE (3)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise;

Current Product License Number PSE-CSW-I-US-20180709)

1 EA $ $

5 OPTION PERIOD FOUR (4)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise;

Current Product License Number PSE-CSW-I-US-20180709)

1 EA $ $

vi. Description

STATEMENT OF WORK (SOW) gSOLIDS Licenses

1. Background

The Office of Pharmaceutical Quality/ Immediate Office (OPQ IO) utilizes the gSOLIDS modeling software for systematic risk assessment of continuous pharmaceutical manufacturing processes.

gSOLIDS contains the capabilities to provide dynamic, high-fidelity models and advanced model validation, process optimization and custom modelling capabilities in addition to the basic, steady-state models available in general solids process modelling tools. gSOLIDS have the following applications: 1) Extract better kinetic information from fewer experiments; 2) Quantify the risk associated with imperfect knowledge of process; 3) Design information rich experiments; 4) Flexible and reliable continuous process. This software is approved for use on the FDA Network.

2. Objective/Scope

The objective is to renew the existing gSOLIDS license in accordance to the delivery schedule. The licenses shall be term licenses.

3. Deliverables

The contractor shall deliver the quantities ordered via email in accordance to the delivery schedule to:

TBD at time of award

Description Qty Unit Delivery Schedule

BASE PERIOD

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise; Current Product License Number PSE-CSW-I-US-20180709)

1 EA by May 1, 2019

OPTION PERIOD ONE (1)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise; Current Product License Number PSE-CSW-I-US-20180709)

1 EA by May 1, 2020

OPTION PERIOD TWO (2)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise; Current Product License Number PSE-CSW-I-US-20180709)

1 EA by May 1, 2021

OPTION PERIOD THREE (3)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise; Current Product License Number PSE-CSW-I-US-20180709)

1 EA by May 1, 2022

OPTION PERIOD FOUR (4)

gSOLIDS Licenses (Software Manufacturer: Process System Enterprise; Current Product License Number PSE-CSW-I-US-20180709)

1 EA by May 1, 2023

4. Inspection/Acceptance Criteria

Inspection and acceptance will occur at the place of delivery. Inspection will include verifying all parts were received and warranties and services are in place. The Government will accept goods, reports and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery. The Government will reject non-conforming products and services.

The contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

5. Authorized Contractor

The contractor shall be the software Original Equipment Manufacturer (OEM) or an authorized reseller/servicing agent of the software OEM.

The contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM.

6. Contract Type

This is a firm fixed price purchase order.

7. Government Points of Contact

Contract Specialist Michelle Dacanay U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, Office# 41025B Beltsville, MD 20705 301-796-0447 Michelle.Dacanay@fda.hhs.gov

Contracting Officer Phillip Frame U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, Office# 42053 Beltsville, MD 20705 240-402-7578 Phillip.Frame@fda.hhs.gov

Technical Point of Contact TBD at time of award U.S. Food and Drug Administration Center for Drug Evaluation and Research

WO51 RM 4153

10903 New Hampshire Ave Silver Spring, MD 20993

8. Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

9. Order of Precedence

The contractor shall follow the terms and conditions of this order. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the contractor’s document, the order of precedence shall be as specified in FAR Clause 52.212-4 of the contract. Any indemnification language indemnifying the contractor of any liability and governing law language in the contractor’s terms and conditions shall be invalid and shall be stricken and removed from this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order.

ix. The provision at 52.212-2, Evaluation—Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under sections v) and vi) of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable.

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

x. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov

2017), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

xi. The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Jan 2017), applies to this acquisition with the following addenda:

https://www.sam.gov/portal

Invoice Submission:

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC). The TPOC is indicated in the Government Points of Contact section.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR

Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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 (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

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

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in

(i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and

Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received.

When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders—Commercial Items (Jan 2018), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition:

▪ 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018)

▪ 52.219-06 Notice of Total Small Business Set-Aside (Nov 2011)

▪ 52.222-3 Convict Labor (June 2003)

▪ 52.222-19 Child Labor—Cooperation With Authorities and Remedies (Jan 2018)

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

▪ 52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246)

▪ 52.222-35 Equal Opportunity for Veterans (Jul 2015) (38 U.S.C. 4212)

▪ 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793)

▪ 52.222-50 Combating Trafficking in Person (Mar 2015)

▪ 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513)

▪ 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008)

▪ 52.232-33 Payment by Electronic Funds Transfer— System for Award Management (Jul 2013)

(31 U.S.C. 3332)

xiii. Additional contract requirement(s) or terms and conditions

FAR/HHSAR PROVISIONS

FAR 52.212-1 Instructions to Offerors- Commercial Items (JAN 2017) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/.

(End of Clause)

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

FAR CLAUSES

FAR 52.252-2 -- Clauses Incorporated by Reference. (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/.

(End of Clause)

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

(a) The Government may extend the term of this contract by written notice to the Contractor prior to expiration of term provided that the Government gives the Contractor a preliminary written notice of its intent to extend at any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause) https://www.acquisition.gov/ https://www.acquisition.gov/

FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.233-3 Protest after Award (Aug. 1996) FAR 52.233-4 Applicable Law for Breach Of Contract Claim (OCT 2004)

HHSAR CLAUSES

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

▪ E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

▪ E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

▪ E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

▪ E205 Electronic Content (Appendix A, Application and Scoping)

▪ 302 Functional Performance Criteria (Appendix C, Application and Scoping

Requirements)

▪ Chapter 4 Hardware

▪ Chapter 6 Support Documentation

▪ E207 Software (Appendix A, Application and Scoping Requirements)

▪ Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical

Requirements)

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

xiv. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions shall reference solicitation number 19-FDA-SOL-1210258.

Questions must be submitted by April 15, 2019 by 2:00 PM EST to all point of contacts listed below.

All quotes must be submitted via email to the point of contacts listed below on or before April 19, 2019 by 10:00 AM EST.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

xv. Point of Contacts: Michelle Dacanay at Michelle.Dacanay@fda.hhs.gov.

Phillip Frame at Phillip.Frame@fda.hhs.gov mailto:Michelle.Dacanay@fda.hhs.gov mailto:Phillip.Frame@fda.hhs.gov