Attachment to Amendment 0003 SPE2D2-21-R-0116.pdf

Attachments for Amendment 0003 SPE2D2-21-R-0116

Solicitation Page 2 is amended as follows to include the 30 case count:

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

ESTIMATED

QUANTITY

22.

UNIT

23.

UNIT

PRICE

24.

AMOUNT

0001AA

0001AB

0001AC

0001AD

0001AE

0002AA

0002AB

0002AC

0002AD

0002AE

0003AA

0003AB

0003AC

0003AD

0003AE

Levalbuterol HCL 0.63MG/3ML Vial (24, 25 or 30 count case)** National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Levalbuterol HCL 1.25MG/3ML Vial (24, 25 or 30 count case)** National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Levalbuterol HCL 0.31MG/3ML Vial (24, 25 or 30 count case)** National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

*CS = ONE CASE

**One case includes 24, 25 or 30 3ML Vials

-The quantities specified in the Schedule are estimates only.

Reference FAR 52.216-21 Requirements for details.

69,259

69,259

70,737

70,737

2,878

2,878

CS*

CS

CS

CS

CS

Solicitation Page 35 is amended as follow to include the 30 count case:

FAR 52.212-1 Addendum 2 -- Preparation & Organization of Proposals

1. Required Documentation

In order for an offeror to be considered for an award the contractor shall submit ONE (1) electronic copy via DIBBS of the following volumes of documentation at or before the closing date and time of the solicitation:

Volume 1 – Non-Price Proposal Volume 2 – Price Proposal

2. Volume Contents. The contents of each volume shall be as follows:

(a) Volume 1 – Non-Price Proposal. Each offeror is required to submit one (1) electronic copy via DIBBS of its non-price proposal which must include:

Technical Requirements:

a. Tab A: Offeror's Signed & Completed SF 1449 and all pages of the solicitation (1 through 99).

b. Tab B: Trade Agreements

Offeror shall fill in the chart below, identifying the Country of Origin of all offered end products in accordance with DFARS 252.225-7020, Trade Agreements Certificate, and DFARS 252.225-7021, Trade Agreements (Currently subject to Class Deviation 2020-O0019), and also identifying the Country of Origin for all Active Pharmaceutical Ingredients (APIs).

Item Number and Description Trade Agreements Act (TAA) Country of Origin of End Product

Country of Origin for active pharmaceutical ingredient (API)

0001 – Levalbuterol HCL 0.63MG/3ML Solution – 24, 25 or 30 count case

0002 – Levalbuterol HCL 1.25MG/3ML Solution – 24, 25, or 30 count case

0003 – Levalbuterol HCL 0.31MG/3ML Solution –

Offerors may be instructed by the Government to provide additional information about the manufacturing, production, and/or transformation process for their offered items, including the origin of components used

Solicitation page 38 is amended as follows to include the 30 count case:

during the three-year period prior to the solicitation issuance date (FEB 2019-FEB 2022). Offerors should not submit contract performance information from prior to three years prior to the solicitation issuance date. Historical sales data is to be broken down by year and month and listed in US currency. Delivered quantities are to be broken down by month, and should identify item nomenclature, NDC, and package size. At a minimum, POC information is to include a name, telephone number, and email address.

b. Tab 2: FDA Violation or Failed Inspection Disclosure – any FDA violations or failed inspection disclosures that are relevant to this solicitation or that are required under applicable laws or regulations shall be included in Volume 1. At a minimum, any FDA violation involving the facilities listed by the offeror on page(s) 70-71 of the solicitation and the items listed in the schedule of supplies (irrespective of dosage and count), occurring in the three years prior to the issuance of the solicitation, is relevant and must be included in Volume 1.

However, other FDA violations may also be relevant, depending on the circumstances of the violation and acquisition. If FDA violations or failed inspection disclosures are non-applicable and the offeror is quoting as a distributor, the offeror must provide a statement that there are no applicable FDA violations or failed inspection disclosures on the part of the distributor and on the part of the manufacturer and any applicable packaging and packing companies and that the distributor and manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. If FDA violations or failed inspection disclosure are non-applicable and the offeror is quoting as a manufacturer, the offeror must provide a statement that there are no applicable FDA violations or failed inspection disclosures on the part of the manufacturer and any applicable packaging and packing companies and that the manufacturer and any applicable packaging and packing companies are in good standing under the applicable laws and regulations.

c. Tab 3: FDA Warning Letter and Corrective Action Plan, if Applicable – any FDA warning letters and applicable corrective action plans that are relevant to this solicitation or that are required under applicable laws and regulations shall be included in Volume 1. If FDA warning letters and corrective action plans are non-applicable and the offeror is quoting as a distributor, the offeror must provide a statement that there are no applicable FDA warning letters and corrective action plans on the part of the distributor and on the part of the manufacturer and any applicable packaging and packing companies and that the distributor and manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. If FDA warning letter and corrective action plans are non-applicable and the offeror is quoting as a manufacturer, the offeror must provide a statement that there are no applicable

FDA warning letters and corrective action plans on the part of the manufacturer and any applicable packaging and packing companies and that the manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations.

• Price Proposal (Solicitation-Volume 2): The government will ensure that each offeror’s

Price proposal will be evaluated against the requirements of the Solicitation. The government will review the price proposal as follows:

Solicitation page 39 is amended as follows to include the 30 count case:

Tab A: Offeror's Proposed Prices. Offerors are required to provide pricing information for line items 0001-0003. For CLIN 0001 offers shall include pricing for 69,259 – Levalbuterol HCL 0.63MG/3ML Vial – 24, 25, or 30 case count. For CLIN 0002 offers shall include pricing for 70,737 – Levalbuterol HCL 1.25MG/3ML Vial – 24, 25 or 30 case count. For CLIN 0003 offers shall include pricing for 2,878 – Levalbuterol HCL 0.31MG/3ML Vial– 24, 25 or 30 case count.

The offeror is required to submit its offered prices for each line item for the base and all option years as stated above as part of the offeror’s price proposal. The final proposal revision, telephonic negotiations and/or email negotiations may be used to determine the lowest price evaluated (unit price per case).

Extraneous Data: Offerors are not to include extraneous data such as, annual reports, marketing brochures, catalogs, etc.

In conducting the evaluation, the Defense Logistics Agency (DLA) will use information provided by the offeror in the proposal. The burden is on the offeror to provide a complete and thorough proposal. Proposals that are missing information or components identified above will be considered incomplete and may be eliminated from further consideration of award.

FAR 52.212-1 Addendum 3 -- Volume 2 - Price Proposal

Organization of Offered Prices: Offerors are required to provide the following mandatory pricing information, expressed in dollars as a unit price per case, for line items 0001 through 0003:

The offeror is required to submit offered prices for each line item for the base and all option years as stated above as part of the offeror’s price proposal. The final proposal revision, telephonic negotiations and/or email negotiations may be used to determine the lowest price.

FAR 52.212-1 Addendum 4 – Caution Statements and Notifications

1. Lowest Price Technically Acceptable Acquisition, This is a lowest price technically acceptable (LPTA) acquisition. The contract will be issued to the responsible offeror whose proposal is determined to be technically acceptable and provides the lowest evaluated aggregate price. The lowest evaluated aggregate price will be determined by multiplying the estimated quantity for each line item, including options, by the offered unit price and then adding the total of each line.

2. Pricing and the Veteran’s Health Care Act of 1992 Offerors shall comply with Department of Veterans Affairs (DVA) policy contained in DVA letter dated March 31, 2004 (or the most current letter expressing this policy). This Federal Ceiling Price (FCP) policy is pursuant to Pub.L.102-585, the Veterans’ Health Care Act of 1992. Contractor shall copy the contracting officer on the letter to DVA referenced on Page 2, item (A) of the DVA’s 3/21/2004 “Dear Manufacturer” letter.

Solicitation page 68 is amended as follows to include the 30 count case:

(End of provision)

FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data. (Alternate IV) (OCT 2010)

(a) Submission of certified cost or pricing data is not required.

(b) Provide information described below:

For a commercial item, the offeror shall submit, at minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include

(A) For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

(B) For market-priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market.

Pursuant to the clause above, please provide the following information:

LINE ITEM 0001: LEVALBUTEROL HCL 0.63MG/3ML VIAL – 24, 25, OR 30 COUNT CASE

All prices exclusive of Federal Excise Tax:

Current (2022) Commercial List Price: ___________

Previous (2021) Commercial List Price: ___________

2022 Federal Supply Schedule Price: ___________

2021 Federal Supply Schedule Price: ___________

2022 Federal Ceiling Price ___________

2021 Federal Ceiling Price ____________

Solicitation page 69 is amended as follows to include the 30 count case:

LINE ITEM 0002: LEVALBUTEROL HCL 1.25MG/3ML VIAL – 24, 25 OR 30 COUNT CASE

All prices exclusive of Federal Excise Tax:

Current (2022) Commercial List Price: ___________

Previous (2021) Commercial List Price: ___________

2022 Federal Supply Schedule Price: ___________

2021 Federal Supply Schedule Price: ___________

2022 Federal Ceiling Price ___________

2021 Federal Ceiling Price ____________

LINE ITEM 0003: LEVALBUTEROL HCL 0.31MG/3ML VIAL – 24, 25 OR 30 COUNT CASE

All prices exclusive of Federal Excise Tax:

Current (2022) Commercial List Price: ___________

Previous (2021) Commercial List Price: ___________

2022 Federal Supply Schedule Price: ___________

2021 Federal Supply Schedule Price: ___________

2022 Federal Ceiling Price ___________

2021 Federal Ceiling Price ____________

FAR 52.215-6 Place of Performance (OCT 1997)

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation, intends, does not intend [check applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

Pursuant to the provision above, please review and provide the required information:

The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for the pharmaceutical products included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Paragraph 4 below will be considered for award. Before a contract

Solicitation page 70 is amended as follows to include the 30 count case:

can be awarded, any successful offeror’s (or its source’s) facilities shall have a current acceptable cGMP status with FDA.

2. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility.

Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be in compliance with applicable FDA cGMP standards prior to contract award.

3. Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered.

4. If the finished products to be offered are of foreign manufacture, the complete name and address of the manufacturer shall be provided below. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

☐OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE

PRODUCTS OFFERED ON THIS SOLICITATION.

☐OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION. THE

PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE

FOLLOWING LOCATIONS:

(Name of Manufacturing Company)

(Street Address) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

TABLETS, CAPSULES AND PILLS

Item Complete Address of

Facility Where Ingredients are Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Levalbuterol HCL

0002 - Levalbuterol HCL

PACKAGING

Facilities Where Intermediate Containers will be Filled and Labeled

Point of Contact Including Phone Number

0001 – Levalbuterol HCL

PACKING

Facilities Where Products will be Packed and Prepared for Shipment

Point of Contact Including Phone Number

0001 – Levalbuterol HCL

Solicitation Page(s) 99 is amended as follows to include the 30 count case:

Appendix B: Agency Annual Demand Projections

DESCRIPTION PCK SZ (Case)

EST

QTY

(YR) UoU

DoD LEVALBUTEROL HCL 0.63MG/3ML VIAL 24, 25 or 30 3MLVials per case 2,125 LEVALBUTEROL HCL 1.25MG/3ML VIAL 24, 25 or 30 3MLVials per case 3,966 LEVALBUTEROL HCL 0.31MG/3ML VIAL 24, 25 or 30 3MLVials per case 252

VA

LEVALBUTEROL HCL 0.63MG/3ML VIAL 24, 25 or 30 3MLVials per case 67,111 LEVALBUTEROL HCL 1.25MG/3ML VIAL 24, 25 or 30 3MLVials per case 66,745 LEVALBUTEROL HCL 0.31MG/3ML VIAL 24, 25 or 30 3MLVials per case 2,623

IHS

LEVALBUTEROL HCL 0.63MG/3ML VIAL 24, 25 or 30 3MLVials per case 19 LEVALBUTEROL HCL 1.25MG/3ML VIAL 24, 25 or 30 3MLVials per case 25 LEVALBUTEROL HCL 0.31MG/3ML VIAL 24, 25 or 30 3MLVials per case 2

BOP

LEVALBUTEROL HCL 0.63MG/3ML VIAL 24, 25 or 30 3MLVials per case 4 LEVALBUTEROL HCL 1.25MG/3ML VIAL 24, 25 or 30 3MLVials per case 1 LEVALBUTEROL HCL 0.31MG/3ML VIAL 24, 25 or 30 3MLVials per case 1

TOTAL

LEVALBUTEROL HCL 0.63MG/3ML VIAL 24, 25 or 30 3MLVials per case 69,259 LEVALBUTEROL HCL 1.25MG/3ML VIAL 24, 25 or 30 3MLVials per case 70,737 LEVALBUTEROL HCL 0.31MG/3ML VIAL 24, 25 or 30 3MLVials per case 2,878