W6369-20A045/A - Smallpox Therapeutic Drug (TPOXX) (W6369-20A045/A)

Trade Agreement: Canadian Free Trade Agreement (CFTA) Tendering Procedures: Generally only one firm has been invited to bid Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address:

Meridian Medical Technologies, Inc. 6350 Stevens Forest Road Suite 301 Columbia Maryland United States 21046 Nature of Requirements:

Purpose of ACAN:

Public Services and Procurement Canada proposes to negotiate a contract with Meridian Medical Technologies Inc. on behalf of the Department of National Defence (DND) for the purchase of TPOXX®.

Definition of Requirement:

TPOXX® is a therapeutic drug used for the treatment of human smallpox disease. DND policy requires that its employees and Canadian Armed Forces members involved in domestic or international operations can carry out their functions in a biological warfare threat environment with minimum disruption of the operation and without significant casualties. To counter the validated threat of smallpox, DND must procure and maintain a stockpile of a drug to treat smallpox.

Quantities:

The estimated quantity for the firm delivery is 2,500 treatment courses, with 12,825 treatment courses in optional quantities.

Term of Contract:

A four year term from contract award.

Evaluation Criteria:

1) The drug must have current regulatory approval by one of the following organizations: Health Canada (HC), the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), or the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA).

2) The drug must be for the treatment of human smallpox disease caused by variola virus, as approved by either HC, the FDA, EMA, or MHRA.

3) The product must be stable when stored at 20°C to 25°C, with a minimum of seven years of approved shelf life from the date of manufacture of the final drug product when stored within the approved temperature range.

4) The Vendor must supply the initial requirement of 2500 treatment courses of TPOXX® with a delivery date between 01 April and 30 June 2020, with at least 5 years of shelf life.

Delivery:

On or before 30 June 2020 for the firm quantity. As and when required for the optional quantities.

Limited Tendering Reason:

In accordance with Government Contract Regulations (GCRs Part 1 - Conditions of Contract Entry - Bids - 6.(d)) Meridian Medical Technologies Inc, is the only known supplier of a licensed therapeutic drug used for the treatment of human smallpox disease with either HC, the FDA, EMA, or MHRA. Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award.

However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.