Revisions as per Amendment 0003.pdf

SOLICITATION NO. SPE2D2-21-R-0109 Page 2 of 103

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

0004AA

0004AB

0004AC

0004AD

0004AE

0005AA

0005AB

0005AC

0005AD

0005AE

Azithromycin 500 MG Tablet – 3 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Azithromycin 500 MG Tablet – 30 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Azithromycin 250 MG Tablet – 6 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Azithromycin 250 MG Tablet – 30 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

Azithromycin 600 MG Tablet – 30 Count* National Drug Code (NDC) ____-___-____ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4

*Package size is unit of use and is subject to Statement of Work - “Preparation for Delivery” requirement.

**BT = One Bottle

- The quantities specified in the Schedule are estimates only.

Reference FAR 52.216-21 Requirements for details.

8,174

8,174

11,215

11,215

103,704

103,704

87,782

87,782

BT**

BT

BT

BT

BT

BT

BT

SOLICITATION NO. SPE2D2-21-R-0109 Page 37 of 103

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 103).

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).

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 in the items’ creation. The Government may use this information to

SOLICITATION NO. SPE2D2-21-R-0109 Page 70 of 103

(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: AZITHROMYCIN TABLET 500 MG – 3 COUNT BOTTLE

All prices exclusive of Federal Excise Tax:

Current (2021) Commercial List Price: ___________

Previous (2020) Commercial List Price: ___________

2021 Federal Supply Schedule Price: ___________

2020 Federal Supply Schedule Price: ___________

2021 Federal Ceiling Price ___________

2020 Federal Ceiling Price ____________

LINE ITEM 0002: AZITHROMYCIN TABLET 500 MG – 30 COUNT BOTTLE

All prices exclusive of Federal Excise Tax:

Current (2021) Commercial List Price: ___________

SOLICITATION NO. SPE2D2-21-R-0109 Page 71 of 103

Previous (2020) Commercial List Price: ___________

2021 Federal Supply Schedule Price: ___________

2020 Federal Supply Schedule Price: ___________

2021 Federal Ceiling Price ___________

2020 Federal Ceiling Price ____________

LINE ITEM 0003: AZITHROMYCIN TABLET 250 MG – 6 COUNT BOTTLE

All prices exclusive of Federal Excise Tax:

Current (2021) Commercial List Price: ___________

Previous (2020) Commercial List Price: ___________

2021 Federal Supply Schedule Price: ___________

2020 Federal Supply Schedule Price: ___________

2021 Federal Ceiling Price ___________

2020 Federal Ceiling Price ____________

LINE ITEM 0004: AZITHROMYCIN TABLET 250 MG – 30 COUNT BOTTLE

All prices exclusive of Federal Excise Tax:

Current (2021) Commercial List Price: ___________

Previous (2020) Commercial List Price: ___________

2021 Federal Supply Schedule Price: ___________

2020 Federal Supply Schedule Price: ___________

2020 Federal Ceiling Price ____________

SOLICITATION NO. SPE2D2-21-R-0109 Page 72 of 103

LINE ITEM 0005: AZITHROMYCIN TABLET 600 MG – 30 COUNT BOTTLE

All prices exclusive of Federal Excise Tax:

Current (2021) Commercial List Price: ___________

Previous (2020) Commercial List Price: ___________

2021 Federal Supply Schedule Price: ___________

2020 Federal Supply Schedule Price: ___________

2020 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:

1. 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 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 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.

SOLICITATION NO. SPE2D2-21-R-0109 Page 74 of 103

TABLETS, CAPSULES AND PILLS

Item Complete Address of Facility Where Ingredients are

Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Azithromycin Tablet 500 MG, 3 Count Bottle

0002 – Azithromycin Tablet 500 MG, 30 Count Bottle

0004 – Azithromycin Tablet 250 MG, 6 Count Bottle

0005 – Azithromycin Tablet 250

0008 – Azithromycin Tablet 600

SOLICITATION NO. SPE2D2-21-R-0109 Page 75 of 103

PACKAGING

Item Complete Address of Facilities Where Intermediate Containers will be Filled and Labeled

Point of Contact Including Phone Number

SOLICITATION NO. SPE2D2-21-R-0109 Page 76 of 103

PACKING

Item Complete Address of Facilities Where Products will be Packed and Prepared for Shipment

Point of Contact Including Phone Number

New Drug Applications (NDA)

Offerors shall represent below information pertaining to FDA approval of New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), when such approval is a prerequisite to marketing, and container/closure system information relative to product stability. (If additional space is needed, the required information may be provided in an attachment to the offer.)

(a) NDA/ANDA.

Item ___________________________, FDA Approval File Number _______________________, Date of FDA approval _________________________.

(b) CONTAINER/CLOSURE SYSTEM MATERIALS.

(describe)