M5-Q50A-03-R8: 65IB Drugs, Pharmaceuticals & Hematology Related Products Solicitation Refreshment

Amendment / Modification

This amendment (0010) modifies Solicitation M5-Q50A-03 dated 06/21/2018.

Key changes include:

• Incorporation of Clauses: The following clauses and provisions are updated or added:

  • GSAM/GSAR 552.238-116, Option to Extend the Term of the FSS Contract (MAR 2022) - New
  • FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) - Updated
  • A-FSS-11, Consideration of Offers Under Standing Solicitation (DEC 2022) - New

• The Schedule section of the solicitation is updated.

• Specific clauses and provisions are detailed on pages 2 and 3 of the amendment.

• This amendment updates contract terms related to options for extending the contract term and the consideration of offers under a standing solicitation.

• Offerors must acknowledge receipt of this amendment.

• The original solicitation's terms and conditions remain in effect, except as modified by this amendment.

Form / Attachment / Pricing Sheet

This Excel file contains pricing and product information required for proposals related to the opportunity. It includes multiple sheets detailing different aspects of pricing, product specifications, manufacturing locations, and non-manufacturer information.

• ALL Other SINs - Proposal: Details product information, pricing (commercial, MFC, TC, FSS), discounts, and tracking customer information for various Special Item Numbers (SINs).
• Definitions & Examples: Provides definitions for terms like 'Package Size' and units of sale/measure, along with examples of how to format product descriptions and pricing.
• Figure 515.4-2 CSP-1: A template for providing pricing proposal data, including customer, discount, quantity/volume, FOB terms, and additional concessions.
• ManufPlaceOfPerf: Requires information on manufacturing facilities, including FEI numbers, owner details, and points of contact for each place of performance.
• NonManufacturers: Details for non-manufacturing distributors, including manufacturer information, product descriptions, and discount structures.
• Price Analysis: A sheet for analyzing and comparing commercial list prices, MFC prices, and proposed government prices.
• Award: Lists awarded SINs, product details, and pricing information.

Bidders must use these sheets to accurately populate their pricing proposals, provide required product and manufacturing details, and ensure compliance with the solicitation's pricing and submission requirements. The 'Definitions & Examples' and 'Figure 515.4-2' sheets are particularly important for correct formatting and data entry.

Amendment / Modification

This amendment revises clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)". The primary change is a reduction in the grace period for reporting sales and remitting the Industrial Funding Fee (IFF) from 60 days to 30 days after the close of the reporting quarter. Fiscal Year 2024 Quarter 1 sales reporting must adhere to this new 30-day timeframe.

• Clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)"

• Bidders must now report sales and remit the IFF within 30 calendar days following the completion of each reporting quarter, instead of the previous 60 days.

• The IFF rate remains 0.5% of total quarterly sales.

• Failure to comply with timely reporting and remittance can result in contract termination for cause.

Form / Attachment / Pricing Sheet

This document is an Excel file containing pricing proposal details for "ALL Other SINs" related to the opportunity. It serves as a template for bidders to provide their pricing information.

• Product Information: Includes columns for SIN#, NDC, product type, generic name, trade name, package size, unit of sale, quantity, unit packaging, unit of measure, and FDA application number.
• MFC Information: Captures Manufacturer's Suggested Retail Price (MSRP) or equivalent, Manufacturer's Price (MFC), discount percentages, and MFC name.
• TC Information: Details Proposed Tracking Customer (TC) Name, Proposed TC Price, and TC discount percentages.
• FSS Information: Outlines Proposed Federal Supply Schedule (FSS) Price with and without Industrial Funding Fee (IFF), and associated discount percentages.
• Country of Origin: Requires specifying the country of origin for each item.
• Definitions & Examples Sheet: Provides definitions for terms like 'Package Size' and lists units of sale and measures with examples of how to format pricing information.
• Figure 515.4-2 CSP-1 Sheet: Contains instructions and fields for providing specific pricing and sales data, including date ranges for transactional data and disclosure of product lines exceeding 75% of historical government sales.
• NonManufacturers Sheet: Includes columns for SIN#, Manufacturer Name, Manufacturer Part #, Dealer/Reseller Part #, Product Description, Manufacturer List Price, and Dealer/Reseller discount.
• Country Codes Sheet: A reference list of country names and their corresponding codes.

Bidders must use this spreadsheet to populate their pricing proposals accurately. It details the required format for itemized pricing, discounts, and other relevant financial and product information. The "Definitions & Examples" and "Figure 515.4-2" sheets provide crucial guidance on how to correctly complete the pricing structure, which is essential for proposal evaluation.

Form / Attachment / Pricing Sheet

This document, "04_OverseasDeliveryResponse_65IB_R8_6212018.docx," is a vendor response form specifically for offers involving overseas delivery. It must only be completed if the vendor is offering overseas delivery as defined in Document 02 - Vendor Response.

• Overseas Delivery Clauses: Includes various clauses related to overseas shipments, such as "Clauses for Overseas Coverage," "Submission of Offers in the English Language," "Submission of Offers in U.S. Currency," "Non-Manufactured Wood Packaging Material for Export," "Characteristics of Electric Current," "Marking and Documentation Requirements per Shipment," "Transshipments," "Foreign Taxes and Duties," and "Parts and Service."
• Vendor Response Sections: Requires vendors to complete sections for:
  • Continuation of SF 1449 (Blocks 19-21, Schedule of Items), listing specific Special Item Numbers (SINs) related to pharmaceuticals, drugs, and medical supplies.
  • Designation of Geographic Areas/Countries/Zones for intended coverage.
  • Designation of F.O.B. Shipping Term (F.O.B. Destination, F.O.B. Inland Carrier, Point of Exportation, or F.O.B. Inland Point, Country of Importation).
  • Certification Regarding Trafficking in Persons Compliance Plans (required prior to award for certain contracts).
• Proposed Pricing: Outlines the required format for submitting proposed pricing for overseas delivery, including specific spreadsheets for different SIN categories (42-2A Single/Dual Pricing, Other SINs) and detailed product information, commercial list prices, units of sale, and FSS pricing.
• Commercial Sales Practices Format (CSP-1): Requires vendors to detail their commercial sales practices related to overseas locations, including sales to the general public, projected annual sales to the Government, and discounting policies compared to commercial customers.

This document is critical for any bidder intending to offer products for overseas delivery. It details the specific clauses, shipping terms, documentation requirements, and pricing formats that must be adhered to. Bidders must carefully review and complete all relevant sections, particularly regarding F.O.B. terms, pricing structures, and commercial sales practice disclosures, to ensure their offer is compliant and properly evaluated for overseas delivery opportunities.

Amendment / Modification

This amendment (0001) to Solicitation M5-Q50A-03-R8, originally dated 06-21-2018, makes the following key changes:

• Incorporates New Clause: Adds FAR clause 52.204-23, "Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)."
• Revises Multiple Documents: Updates Document 03, which includes:
  • Proposal Price List Preparation
  • Instructions for Pre-Award Review Process
  • Scope of Solicitation
  • Signatory Authority Form
  • Small Business Subcontracting Plan Template
  • FAR clauses 52.219-9 (Alternate II) and 552.211-78 (Tailored)
• Adds Trade Agreements Act Information: Includes Trade Agreements notes/instructions to cover:
  • Scope of Solicitation
  • Trade Agreements Act Non-Availability Determination Request
  • CP-FSS-2 item (7)
  • FAR clauses 52.212-3 (Nov 2017), 52.212-5 (Aug 2018), 52.225-5 (Aug 2018)
  • Letter of Supply (I-FSS-644)

Specific sections and clauses within the original solicitation and its attachments have been revised or added as detailed above. The full text of these changes is provided on continuation pages 2-48, with Document 03 provided as an Excel spreadsheet attachment.

Offerors must acknowledge receipt of this amendment. If an offer has already been submitted, changes may be made via letter or electronic communication referencing this amendment. Failure to acknowledge may result in offer rejection. The effective date of this amendment is September 7, 2018.

Form / Attachment / Pricing Sheet

This document provides pricing sheets for various SINs (Special Item Numbers) related to the opportunity. It details product information, manufacturer (MFC) information, tracking customer (TC) information, and Federal Supply Schedule (FSS) information. Bidders are expected to use these sheets to provide their proposed pricing.

• Sheet: 42-2A Dual - BIG 4 & 42-2A Dual - OGA: These sheets require bidders to input pricing details for specific products, including commercial list price, MFC price, and proposed BIG 4 and OGA prices (with and without IFF). They also include fields for NDC numbers, generic and trade names, package size, unit of sale, unit of measure, and country of origin.
• Sheet: Figure 515.4-2 CSP-1: This sheet requires the entry of a date that is current, accurate, and complete as of 60 calendar days prior to submission. It also outlines columns for customer, discount, quantity/volume, and FOB terms.
• Sheet: NonManufacturers: This sheet is for listing manufacturer details, part numbers, product descriptions, and discounts for non-manufacturer resellers.
• Sheet: Country Codes: Provides a reference list of country codes for use in the pricing sheets.
• Sheet: Price Analysis: This sheet includes columns for comparing commercial list prices, MFC prices, and proposed BIG 4 and OGA prices, along with various discount percentages and price analysis metrics.
• Sheet: Award: This sheet details awarded pricing for both BIG 4 and OGA, including tracking ratios and prices with and without IFF.

This Excel file is critical for bidders to understand the pricing structure and to submit their own competitive price proposals. It outlines the specific data points required for pricing, including discounts, quantities, and product details. Bidders must carefully review and complete the relevant sections of these sheets as part of their proposal submission.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing pricing proposal templates and related information for the opportunity. It includes several sheets for different aspects of pricing and product details.

• 42-2A Single Pricing - Proposal: This sheet requires bidders to provide detailed pricing information for each item, including SIN#, NDC codes, generic and trade names, package details, unit of sale, unit of measure, commercial list price, MFC price, proposed TC price, and proposed FSS price (with and without IFF).
• Definitions & Examples: This sheet provides definitions for units of sale, units of measure, and package size calculations, along with examples to clarify how pricing should be presented.
• Figure 515.4-2 CSP-1: This sheet is for entering specific date information related to the accuracy of the provided data and references instructions for Contractor Sales Price (CSP) reporting.
• NonManufacturers: This sheet appears to be a template for non-manufacturer information, including SIN#, manufacturer details, and discount information.
• Price Analysis: This sheet is for analyzing and comparing Manufacturer's First Cost (MFC), Contractor's Proposed Price (FCP), and Tracking Customer (TC) prices against commercial list prices and proposed FSS prices.
• Award: This sheet lists awarded single pricing details, including SIN#, product information, and government prices.
• Country Codes: This sheet provides a reference for country codes used in other sections.

Bidders must use the provided templates, particularly the '42-2A Single Pricing - Proposal' and 'Price Analysis' sheets, to submit their pricing information accurately. The 'Definitions & Examples' sheet is crucial for understanding how to format pricing correctly. The 'Figure 515.4-2 CSP-1' sheet requires specific date input as per solicitation instructions. The 'NonManufacturers' and 'Award' sheets provide context on non-manufacturer considerations and awarded pricing, respectively.

Amendment / Modification

This amendment (0002) to Solicitation M5-Q50A-03-R8, dated 06-21-2018, corrects the "Notice Regarding Prime Vendor Sales & Distribution and Pricing Agreements (DAPA)". The correction removes the exemption for DAPA sales and certain orders placed under the MSPV program, meaning these sales will now be reported as FSS sales and subject to the Industrial Funding Fee (IFF).

• Clause 552.238-74 Industrial Funding Fee and Sales Reporting (Jan 2016, Tailored).

• The "Notice Regarding Prime Vendor Sales & Distribution and Pricing Agreements (DAPA)" has been revised and retitled "Notice Regarding Schedule Sales (FEB 2019)".

• The old version of the notice from the original solicitation (M5-Q50A-03-R8) is also provided for comparison.

• The effective date of this amendment is March 29, 2019.

• Offerors must acknowledge receipt of this amendment. Failure to do so may result in rejection of the offer.

• If an offeror wishes to change a previously submitted offer due to this amendment, the change must be submitted in writing and received prior to the specified opening hour and date.

Form / Attachment / Pricing Sheet

This document is an Excel file containing pricing proposal details for "ALL Other SINs" (Special Item Numbers). It serves as a template for bidders to provide their pricing information for various products.

• Product Information: Includes columns for SIN#, NDC (National Drug Code) identifiers, product type, generic name/strength, trade name/strength, package size, unit of sale, quantity per unit of sale, unit packaging, quantity per unit package, and unit of measure.
• Pricing Information: Columns for Commercial List Price, MFC (Manufacturer's Cost) Price, MFC discount percentage, Proposed TC (Tracking Customer) Price, TC discount percentage, Proposed FSS (Federal Supply Schedule) Price without IFF (Industrial Funding Fee), and Proposed FSS Price with IFF.
• Analysis Columns: Includes fields to compare TC pricing against MFC pricing and a proposed TC ratio.
• Country of Origin: A column to specify the country of origin for each product, referencing a separate "Country Codes" sheet.

This sheet is critical for bidders to accurately populate their proposed pricing for all applicable SINs. It requires detailed information about each product, including quantities, units of measure, and pricing structures (Commercial List Price, MFC Price, TC Price, FSS Price). Bidders must carefully fill out this sheet according to the solicitation's instructions to ensure their proposal is complete and compliant. The "Definitions & Examples" sheet provides further guidance on interpreting and completing fields like "Package Size" and units of measure.

Amendment / Modification

This amendment (0003) to Solicitation M5-Q50A-03-R8, dated 06-21-2018, makes the following updates:

• Electronic Acceptance of Offers: The "Electronic Acceptance of Offers (Aug 2019)" provision has been revised. The requirement to sign the Signatory Authority Form within 10 days of proposal submission is removed. The maximum file submission size has been increased to 10MB.

• FAR/GSAR Clauses and Provisions: Several FAR and GSAR clauses and provisions have been added, removed, or revised. Key additions include FAR clauses related to Telecommunications and Video Surveillance Services or Equipment (52.204-24, 52.204-25), Task-Order and Delivery-Order Ombudsman (52.216-32), and Evaluation of Options (52.217-5). Several GSA clauses have also been updated or revised.

• Small Business Subcontracting Plan Template: The "Small Business Subcontracting Plan Template (April 2019)" has been revised.

• Price Proposal Preparation: Document 03, "Price Proposal Preparation," has been revised and is available as an Excel file attachment.

• Electronic Acceptance of Offers (Aug 2019)

• FAR and GSAR clauses and provisions (detailed list provided in the amendment)

• Small Business Subcontracting Plan Template (April 2019)

• Document 03 – Price Proposal Preparation

• The deadline for submitting the Signatory Authority Form has been removed.

• The maximum file size for electronic submissions has increased to 10MB.

• Offerors should review the updated FAR/GSAR clauses and the revised Price Proposal Preparation document for any changes impacting their proposals.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing pricing proposal information, specifically for the '42-2A Single Pricing - Proposal' sheet. It outlines the required fields for vendors to submit detailed pricing for offered products under specific SINs (Special Item Numbers).

• Product Information: Includes fields for SIN, NDC numbers, generic/trade names, strength, package size, unit of sale, unit of measure, and FDA application number.
• Pricing Details: Requires Commercial List Price, MFC Price, MFC % Off Commercial List Price, Proposed Tracking Customer (TC) Name and Price, and Proposed FSS Price (with and without IFF).
• Country of Origin: Requires specifying the country of origin for each product.
• Tracking & Sales Data: Includes fields for total units sold and total sales ($) for both commercial and government entities during a prior fiscal year or a more recent 12-month period.
• Definitions & Examples Sheet: Provides definitions for units of sale, units of measure, and package size, along with examples of how to format this information.
• Country Codes Sheet: Lists country codes for use in the 'Country of Origin' field.
• Figure 515.4-2 CSP-1 Sheet: Requires specific dates related to transactional data and commercial agreements used for pricing.
• ManufPlaceOfPerf Sheet: Requires details on manufacturing facilities and places of performance.
• NonManufacturers Sheet: Requires information on non-manufacturers and their discounts.
• Price Analysis Sheet: Summarizes MFC, FCP, and TC pricing analysis.
• Award Sheet: Details FSS Awarded Single Pricing.

This document is critical for bidders to understand the pricing structure and provide accurate, compliant pricing proposals. It details the specific data points required for each product offered, including discounts, pricing tiers, and sales history. Bidders must carefully complete all relevant sections of this spreadsheet according to the provided definitions and examples to ensure their proposals are evaluated correctly.

Amendment / Modification

This amendment (0004) to Solicitation M5-Q50A-03-R8, dated 06-21-2018, makes the following updates:

• Item 1: Electronic Acceptance of Offers (Mar 2020) and Proposal Submission Checklist (Mar 2020):

  • Revises procedures for electronic offer submission, emphasizing the use of digital signatures for documents requiring wet signatures. Scanned copies of wet-signed documents are still acceptable. Typed names or images of signatures are not.
  • Clarifies that the SF1449 signature date must be no earlier than 10 calendar days prior to proposal submission.
  • Updates the Proposal Submission Checklist to reflect current requirements, including electronic submission to FSSOffersandExtensions@va.gov and specific file format requirements (Word/PDF for fill-ins, Excel for price lists).
  • Reiterates that hard copies, CDs, thumb drives, and zip files are generally not accepted.

• Item 2: Regulatory Updates:

  • Adds, removes, and revises various FAR, GSAR, and VAAR regulations. Specific clauses updated include:
    • 52.229-3 FEDERAL, STATE, AND LOCAL TAXES (FEB 2013)
    • 552.238-112 DEFINITION (FEDERAL SUPPLY SCHEDULES) - NON-FEDERAL ENTITY (MAY 2019)
    • 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)
    • 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) (TAILORED – FEB 2020)
    • 52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2020)
    • 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)
    • 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)
    • 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)
    • 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

• Electronic Acceptance of Offers (Mar 2020)

• Proposal Submission Checklist (Mar 2020)

• Various FAR, GSAR, and VAAR clauses as listed above.

• Offerors must adhere to the updated electronic submission protocols and signature requirements.

• The SF1449 signature date restriction is critical.

• Bidders should review all updated clauses for compliance.

Amendment / Modification

This amendment (Number 0005, effective 12-30-2020) modifies the original solicitation (M5-Q50A-03-R8, dated 06-21-2018).

Key changes include:

• Addition of clause 52.219-33, Nonmanufacturer Rule (Mar 2020).

• Revision of FAR and GSAR regulations, specifically AS5000 Pharmaceutical Prime Vendor Participation (Dec 2020) and the Small Business Subcontracting Plan Template (Oct 2020).

• Updates to numerous other FAR clauses and regulations, with specific new and old versions listed in the document.

• Various FAR clauses and regulations have been updated or replaced with newer versions.

• The "Solicitation Updates" section details the specific changes.

• Offerors must acknowledge receipt of this amendment.

• Any changes to previously submitted offers must be made via letter or electronic communication referencing this amendment.

• The document does not explicitly state a change to the hour and date for receipt of offers, but it is implied that offerors must acknowledge receipt of this amendment prior to that time.

Amendment / Modification

This amendment approves a class deviation to Federal Acquisition Regulation (FAR) subpart 22.8, Equal Employment Opportunity. It stops the enforcement of FAR policies related to the now revoked Executive Order 11246, Equal Employment Opportunity, and aligns with Executive Order (E.O.) 14173, which ended illegal discrimination and restored merit-based opportunity.

Pages 2-13 of the document contain a summary of changes and updated clauses related to this deviation.

This amendment does not extend the hour and date specified for receipt of offers. Offerors must acknowledge receipt of this amendment. If an offer already submitted needs to be changed due to this amendment, the change must be made by letter or electronic communication referencing the solicitation and amendment numbers, and received prior to the opening hour and date specified.

Amendment / Modification

This amendment (0009) to solicitation M5-Q50A-03, originally dated 06/21/2018, introduces the following updates:

• Incorporation of GSAM Clause: GSAM Clause 552.238-120, "Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored) (Sep 2024)", is now included. This clause outlines procedures for economic price adjustments based on established methods, including definitions, general provisions, exceptions, specific methods for SIN 42-2A and Schedule 66 III, submission requirements, and contracting officer responsibilities.
• Updated Responsibility Evaluation: The "Responsibility Evaluation" section has been updated as of October 2025. For new VA Federal Supply Schedule (FSS) offers, it details requirements for contractor qualifications and financial information, including providing annual financial statements (audited if available) or alternative documentation for new contractors with less than two years of experience. It emphasizes the need for adequate financial resources to perform the contract.
• Updated Signature Authority Form: The "Signature Authority" form has been updated as of August 2025. This form clarifies the process for identifying individuals authorized to sign FSS offers and contracts, distinguishing between company officers and other delegated individuals.

• GSAM Clause 552.238-120 replaces GSAM/R 552.216-70.

• The "Responsibility Evaluation" section is updated.

• The "Signature Authority" form is updated.

• The amendment does not explicitly state a change to the hour and date for receipt of offers, but it is standard practice to acknowledge receipt of amendments. Offerors must acknowledge receipt of this amendment as specified in Item 11 of the SF 30 form.

Solicitation

This document is a solicitation for a Worldwide Federal Supply Schedule (FSS) Contract for Drugs, Pharmaceuticals & Hematology Related Products (FSC Group 65, Part I, Section B). It outlines the terms and conditions for vendors to offer these products to the Department of Veterans Affairs (VA) and other federal agencies.

• Product Scope: Drugs and Biologicals (FSC Class 6505), Medicated Cosmetics and Toiletries (FSC Class 6508).

• Technical Requirements: Includes clauses on National Drug Codes, Bar Coding (GS1-128 or HIBCC compliant), Therapeutic Equivalence (FDA "A" rating required for SINs 42-2a and 42-2b), Recalls, Labeler Codes, and New Drug Applications.

• Contractual Terms: Incorporates numerous FAR and GSA clauses covering contract terms and conditions, ordering procedures, inspection, payment, disputes, and reporting requirements.

• Compliance: Requires adherence to various regulations including those related to small business utilization, environmental attributes, and safeguarding of contractor information systems.

• Contract Type: Fixed-price with economic price adjustment, indefinite delivery, indefinite quantity (IDIQ) Multiple Award Schedule contracts.

• Period of Performance: Contracts are typically for 5 years, with options to extend up to 10 years.

• Minimum Sales Criteria: Vendors are expected to exceed $25,000 in sales within the first two years and annually thereafter.

• Submission: Offers must be submitted electronically via email to vafssoffers@va.gov. Paper offers are not accepted. Specific formatting and signature requirements apply.

• Evaluation: Awards will be made to responsible offerors providing reasonable pricing and conforming to the solicitation, considering best value.

• Key Deadlines: Offers are accepted on a continuous basis under this standing solicitation (A-FSS-11). However, specific proposal submission and signature dates may apply.

• Open to all responsible offerors.

• Various small business set-aside clauses are incorporated, indicating potential for orders to be set aside for small business, HUBZone, veteran-owned, service-disabled veteran-owned, small disadvantaged, women-owned, and economically disadvantaged women-owned small businesses.

• Significant Changes: The document details numerous changes from the previous solicitation (M5-Q50A-03-R7), including added, removed, and updated clauses and provisions.

• Electronic Submission: All offers must be submitted electronically. 508 compliance is required for all submitted documents.

• Training: New offerors must complete GSA's "Pathway to Success" seminar.

Form / Attachment / Pricing Sheet

This document contains pricing proposal templates and related definitions for the opportunity. Bidders should use these sheets to provide detailed pricing information as required by the solicitation.

• Sheet: 42-2A Single Pricing - Proposal: This sheet requires bidders to enter detailed pricing information for each item, including National Drug Codes (NDCs), commercial list price, manufacturer's (MFC) price, proposed tracking customer (TC) price, and Federal Supply Schedule (FSS) prices (with and without Industrial Funding Fee - IFF). It also includes columns for package size, unit of sale, unit of measure, and country of origin.
• Sheet: Definitions & Examples: This sheet provides definitions for units of sale, units of measure, and package size, along with examples to clarify how to populate the pricing sheets. It also explains how to include strength information within the generic and trade names.
• Sheet: Figure 515.4-2 CSP-1: This sheet requires specific information related to Contractor Sales Price (CSP) data, including dates for data currency, date ranges for transactional data, and disclosure limitations. It also includes columns for customer, discount, quantity/volume, FOB terms, and additional discounts.
• Sheet: NonManufacturers: This sheet is for reporting manufacturer and dealer/reseller pricing information, including part numbers and discounts.
• Sheet: Country Codes: This sheet provides a reference list of country codes used in the pricing sheets.
• Sheet: Price Analysis: This sheet appears to be for analyzing and comparing different pricing structures (MFC, FCP, TC) against commercial list prices and government prices.
• Sheet: Award: This sheet details FSS awarded single pricing, including awarded government prices with and without IFF.

This Excel file is critical for bidders to understand the pricing structure and requirements of the opportunity. It dictates how pricing must be presented and provides definitions and examples to ensure accurate and compliant submissions. Bidders must carefully review each sheet to prepare their price proposals correctly.

Form / Attachment / Pricing Sheet

This document, "02_VendorResponse_65IB_R8_6212018.docx", is a comprehensive vendor response package required for all offerors responding to the solicitation. It includes various forms and sections that must be completed to ensure a compliant and complete proposal.

• Signatory Authority Form: To identify individuals authorized to sign offers and contracts.
• Agent Authorization: To authorize third-party agents to act on behalf of the company.
• SF-1449: The standard form for soliciting and awarding commercial item contracts, including solicitation number (M5-Q50A-03-R8) and issue date (6/21/2018).
• Continuation of SF-1449 Blocks 19-21, Schedule of Items: Details specific Special Item Numbers (SINs) offered, such as SIN 42-1 (Non-prescription medicated cosmetics & surgical soaps), SIN 42-2A (Single source drug, innovator multiple source drug, and any biological product), SIN 42-2B (Generic & multiple source pharmaceuticals), SIN 42-3 (Complete IV delivery systems), SIN 42-5 (Nutritional/Dietary Supplements), and SIN 622 (Antiseptic Liquid Skin Cleansing Detergents and Soaps).
• Scope of Solicitation: Defines the Federal Supply Schedule (FSS) program and the scope of products/services accepted, including restrictions related to DSCSA, FDA regulations, and Trade Agreements Act.
• Commercial Sales Practices (CSP): Requires detailed information on proposed pricing, additional discounts, and commercial catalog/pricelist.
• Past Performance Evaluation: Required for new offerors without a current FSS contract.
• Small Business Subcontracting Plan: Required for "other than small businesses" with offers exceeding $700,000.
• Proposal Checklist: A final checklist to ensure all required documents are submitted.

This document is critical for all potential bidders as it outlines the mandatory forms, information, and representations required for a successful proposal submission. Offerors must carefully complete each section, including company information, signatory authority, business size, product offerings under specific SINs, pricing, and compliance statements, to be considered for award. The document also details specific requirements for SIN 42-2A (covered drugs) and general scope limitations.

Form / Attachment / Pricing Sheet

This document contains pricing information for various products, organized by Special Item Number (SIN). It includes columns for manufacturer information, commercial list prices, and proposed pricing for different government channels (BIG 4 and OGA), with and without the Industrial Funding Fee (IFF).

• Sheet: 42-2A Dual - BIG 4: Details product information, manufacturer pricing, tracking customer pricing, and FSS/FCP information. Includes columns for SIN, NDC codes, generic/trade names, package size, unit of sale, quantity, unit of measure, FDA application number, country of origin, commercial list price, MFC price, MFC discount, proposed BIG 4 prices (with and without IFF), and FCP price.
• Sheet: 42-2A Dual - OGA: Similar to the BIG 4 sheet but focuses on Other Government Agency (OGA) pricing.
• Sheet: Definitions & Examples: Provides definitions for terms like 'Package Size' and 'Unit of Sale', and illustrates how to populate the pricing sheets with examples.
• Sheet: Figure 515.4-2 CSP-1: Contains instructions for providing current, accurate, and complete information regarding pricing data, including dates and disclosure limitations.
• Sheet: NonManufacturers: Lists manufacturers, part numbers, product descriptions, and discount information for non-manufacturer offers.
• Sheet: Price Analysis: Consolidates price analysis data for both BIG 4 and OGA pricing, comparing proposed prices against commercial list prices and other benchmarks.
• Sheet: Award: Details awarded pricing for BIG 4 and OGA, indicating awarded status.

This spreadsheet is crucial for bidders to understand the pricing structure, historical pricing, and any awarded pricing for the products related to this opportunity. It provides the necessary data fields and instructions for preparing a compliant price proposal. Bidders must carefully review the definitions and examples to ensure accurate completion of their pricing submissions.

Amendment / Modification

This amendment (0008) to Solicitation M5-Q50A-03-R8, originally dated 06-21-2018, introduces several updates to regulations, special language, and templates/forms. Key changes include:

• Updated Clauses: Several FAR clauses have been updated to newer versions, including:
  • 52.203-17 (Contractor Employee Whistleblower Rights) is now dated Nov 2023.
  • 52.212-3 (Offeror Representations and Certifications - Commercial Products and Commercial Services) is updated to May 2024 with a Feb 2025 deviation.
  • 52.212-5 (Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services) is updated to Jan 2025 with a Feb 2025 deviation.
  • Alternate II of 52.219-9 is incorporated through the updated 52.212-5 clause.
  • 52.226-8 (Encouraging Contractor Policies to Ban Text Messaging While Driving) is updated to May 2024.
• New Responsibility Evaluation Document: A new document for Responsibility Evaluation has been added, which should be completed with options and new offers.

• FAR Clauses: Specific FAR clauses have been updated or incorporated with new versions.

• Responsibility Evaluation: A new document has been added for this purpose.

• The amendment does not explicitly state a change to the hour and date specified for receipt of offers, but bidders should review all updated clauses and the new Responsibility Evaluation document to ensure compliance with their proposals.

Form / Attachment / Pricing Sheet

This document appears to be a pricing sheet or a data collection template related to the "42-2A Dual" contract vehicle. It is designed to capture detailed product information, manufacturer data, tracking customer pricing, and sales history for items offered under specific Special Item Numbers (SINs).

• Product Information: Includes SIN, National Drug Codes (NDC), specialty distribution status, generic and trade names with strength, package size, unit of sale, quantity per unit, unit of measure, FDA application number, and country of origin.
• Sales Data: Requires total units and sales dollars for both commercial and government entities during a prior fiscal year.
• Pricing Information: Captures commercial list price, Manufacturer's Contract (MFC) price, proposed Tracking Customer (TC) price, and proposed "BIG 4" and "Other Government Agency" (OGA) prices, both with and without Industrial Funding Fee (IFF).
• Discounts: Details MFC discount percentage off commercial list price and proposed BIG 4/OGA discount percentages.
• Tracking Customer Information: Includes proposed TC name and price, and total sales to the proposed TC.
• Manufacturing/Place of Performance: Separate sheets request details on manufacturing facilities, including FEI numbers and facility owner information.
• Country Codes: A reference sheet for country codes used in the pricing data.
• Award Information: A sheet to record awarded pricing for BIG 4 and OGA, indicating awarded status.

This document is crucial for bidders as it outlines the specific data required for pricing proposals. Vendors must accurately populate this sheet with product details, sales history, and proposed pricing to comply with solicitation requirements. The pricing and discount information provided will be a key factor in proposal evaluation and contract award.

Amendment / Modification

This amendment (0008) to solicitation M5-Q50A-03-R8, dated 06-21-2018, updates regulations, special language, and templates/forms. It includes a table detailing changes to specific FAR clauses and adds a new Responsibility Evaluation document.

• FAR Clause Updates:

  • 52.203-17: Updated from "June 2020" to "Nov 2023" (Contractor Employee Whistleblower Rights).
  • 52.212-3: Updated to "May 2024" (Deviation Feb 2025) (Offeror Representations and Certifications).
  • 52.212-5: Updated to "Jan 2025" (Deviation Feb 2025) (Contract Terms and Conditions).
  • 52.219-9 (Alternate II): Updated incorporation through 52.212-5.
  • 52.226-8: Updated to "May 2024" (Encouraging Contractor Policies to Ban Text Messaging While Driving).

• New Responsibility Evaluation Document: This document is now required for new offers and subsequent offers of current FSS contracts, requiring completion of Contractor's Qualifications and Financial Information Form or submission of financial statements.

• The amendment extends the hour and date specified for receipt of offers. Offerors must acknowledge receipt of this amendment.

• Bidders should review the updated FAR clauses and the new Responsibility Evaluation document requirements for their proposals.

Amendment / Modification

This amendment (0004) to Solicitation M5-Q50A-03-R8, dated 06-21-2018, makes the following updates:

• Item 1: Electronic Acceptance of Offers (Mar 2020) and Proposal Submission Checklist (Mar 2020):

  • Revises procedures for electronic offer submission, emphasizing the use of specific email addresses, subject line formats, and file types (Word or PDF for fill-in documents, Excel for price lists).
  • Clarifies that only digital signatures or scanned wet signatures are accepted; other electronic signature formats are not valid.
  • Specifies that SF1449 signature dates must be no earlier than 10 calendar days prior to proposal submission.
  • Updates the Proposal Submission Checklist to reflect these electronic submission requirements and signature guidelines.
  • Reiterates that zip files are not accepted and offers exceeding 10MB may require multiple emails, with proper numbering in the subject line.

• Item 2: Regulatory Updates:

  • Adds, removes, and revises various Federal Acquisition Regulation (FAR), General Services Administration Acquisition Regulation (GSAR), and Veterans Affairs Acquisition Regulation (VAAR) clauses. Specific clauses updated or added include:
    • 52.229-3 FEDERAL, STATE, AND LOCAL TAXES (FEB 2013)
    • 552.238-112 DEFINITION (FEDERAL SUPPLY SCHEDULES) - NON-FEDERAL ENTITY (MAY 2019)
    • 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)
    • 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) (TAILORED – FEB 2020)
    • 52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2020)
    • 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)
    • 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)
    • 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)
    • 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

• Electronic Offer Submission Procedures

• Proposal Submission Checklist

• Various FAR, GSAR, and VAAR clauses as listed above.

• Offerors must adhere to the revised electronic submission guidelines, including file formats, email addresses, and subject line requirements.

• The deadline for offer receipt is not extended by this amendment.

• Offerors must acknowledge receipt of this amendment.

Amendment / Modification

This document is an amendment to a solicitation. It approves a class deviation to Federal Acquisition Regulation (FAR) subpart 22.8, Equal Employment Opportunity. This deviation is to stop the enforcement of FAR policies related to the now-revoked Executive Order 11246, Equal Employment Opportunity. It also references Executive Order (E.O.) 14173, which ended illegal discrimination and restored merit-based opportunity.

Pages 2-13 of the amendment contain a summary of changes and updated clauses related to Equal Employment Opportunity.

This amendment does not explicitly state if proposal deadlines, requirements, or evaluation factors were modified. Offerors are instructed to acknowledge receipt of this amendment. Failure to do so may result in the rejection of their offer. If an offeror desires to change an offer already submitted due to this amendment, such change must be made by letter or electronic communication referencing the solicitation and amendment number, and received prior to the opening hour and date specified.

Amendment / Modification

This amendment modifies solicitation M5-Q50A-03-R8 to incorporate revisions to clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)". The primary change is the reduction of the grace period for reporting sales and remitting the Industrial Funding Fee (IFF) from 60 days to 30 days after the close of the reporting quarter. This shortened timeframe applies to FY 24 Q1 sales reporting and subsequent periods.

• Clause 552.238-80, "Industrial Funding Fee and Sales Reporting (Jul 2020, Tailored – Dec 2023)"

• Offerors must acknowledge receipt of this amendment.

• The deadline for reporting sales and remitting the IFF is now 30 calendar days after the end of each reporting quarter, instead of 60 days.

• Failure to comply with timely reporting and remittance may result in contract termination for cause.

Amendment / Modification

This amendment (0005) to solicitation M5-Q50A-03-R8, dated 06-21-2018, updates regulations, special language, and templates/forms. Key changes include:

• Addition: Clause 52.219-33, Nonmanufacturer Rule (Mar 2020).
• Revisions: Updates to FAR and GSAR regulations, specifically AS5000 Pharmaceutical Prime Vendor Participation (Dec 2020), and the Small Business Subcontracting Plan Template (Oct 2020).
• Updated Clauses: Numerous FAR clauses have been updated to newer versions, including definitions, restrictions on subcontractor sales, contractor code of business ethics, whistleblower rights, reporting requirements, CAGE code reporting, telecommunications prohibitions, protection of government interests, instructions to offerors, representations and certifications, contract terms and conditions, and various small business set-aside notices.

This amendment revises numerous FAR clauses and updates specific regulations and templates as detailed in the document. A table on page 2 lists the specific new and old references for these updates.

Offerors must acknowledge receipt of this amendment. If an offer already submitted needs to be changed due to this amendment, it must be done via letter or electronic communication referencing the solicitation and amendment numbers, and received prior to the specified opening hour and date. Failure to acknowledge may result in offer rejection.

Other / Unclassified

This document is a contract award notice for Mesoblast, Inc. It details the award number, effective dates, and the awarded contractor.

This award notice is relevant to potential bidders as it confirms a contract has been awarded to Mesoblast, Inc. for the period of 02/15/2026 to 02/14/2031. The contract is associated with Solicitation Number M5-Q50A-03-R8 and falls under Product/Service Code 6505 and NAICS Code 325412. The award amount is listed as $0.00. The contracting office is the Department of Veterans Affairs, National Acquisition Center in Hines, IL. The Federal Supply Schedule (FSS) Help Desk can be contacted for further information.

Amendment / Modification

This amendment (0009) to Solicitation M5-Q50A-03, dated 06/21/2018, incorporates the following updates:

• GSAM Clause 552.238-120 Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored) (Sep 2024): This new clause replaces GSAM/R 552.216-70. It outlines the definition, general provisions, exceptions, and specific methods for economic price adjustments (EPA) for Federal Supply Schedule contracts, including procedures for price increases and decreases, and submission requirements.
• Responsibility Evaluation (October 2025): Updates to the requirements for assessing offeror responsibility, particularly for new Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) offers. This includes updated guidance on required financial information, contractor qualifications, and documentation for demonstrating financial responsibility.
• Signature Authority form (August 2025): Updates to the form used to identify individuals delegated authority to sign FSS offers and contracts.

• GSAM Clause
• Responsibility Evaluation criteria and forms
• Signature Authority form

This amendment extends the deadline for receipt of offers. Offerors must acknowledge receipt of this amendment. The specific impact on proposal deadlines is not detailed in this amendment text, but offerors should ensure they acknowledge receipt.

Amendment / Modification

This amendment makes the following updates:

• Incorporates GSAM Clause 552.238-120, "Economic Price Adjustment – Federal Supply Schedule Contracts (Tailored)" (September 2024).

• Updates the "Responsibility Evaluation" document to the October 2025 version.

• Updates the "Signature Authority" form to the August 2025 version.

• GSAM Clause 552.238-120 is added.

• Responsibility Evaluation document is updated.

• Signature Authority form is updated.

This amendment does not appear to extend the hour and date specified for receipt of offers. Bidders should review the updated clauses and forms to ensure compliance with the latest requirements.