REVISED Pages 39 to 40.pdf

SOLICITATION NO. SPE2D2-21-R-0105_____________________________Page 39 of 104

a. 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 pages 73-75 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.

b. 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:

Tab A: Offeror's Proposed Prices. Offerors are required to provide pricing information for line items 0001-0006. For CLIN 0001 offers shall include pricing for 154,220 150 MG

Tablets 30 count bottles. For CLIN 0002 offers shall include pricing for 198,391 150 MG

Tablets 90 count bottles. For CLIN 0003 offers shall include pricing for 61,600 150 MG

SOLICITATION NO. SPE2D2-21-R-0105_____________________________Page 40 of 104

Tablets 500 count bottles. For CLIN 0004 offers shall include pricing for 148,033 300 MG

Tablets 30 count bottles. For CLIN 0005 offers shall include pricing for 140,127 300 MG

Tablets 90 count bottles. For CLIN 0006 offers shall include pricing for 35,538 300 MG

Tablets 500 count bottles.

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. Telephonic negotiations and/or email negotiations may be used to determine the lowest price evaluated (unit price per bottle).

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 bottle, for line items 0001 through

0006:

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. 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. If the provisional FCPs are established and/or revised, and known prior to award, the award prices may not exceed the lower of the provisional FCPs or the revised Provisional FCPs.