Duodote Autoinjector

Trade Agreement: CETA/WTO-AGP/CPTPP/CFTA/FTAs with Peru/Colombia/Panama/Korea/UK
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: 

1. Definition of the requirement 

The Department of National Defence (DND) has a requirement for the supply of a dual autoinjector containing atropine and pralidoxime chloride to provide treatment of intoxication resulting from suspected exposure to chemical nerve agents or poisoning by a pesticide. 

2. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements) 

Any interested supplier must demonstrate by way of a statement of capabilities that its product meets the following requirements: 

a) The product must have regulatory approval from the US Food and Drug Administration (FDA) or Health Canada.
b) The product must have an indication for the treatment of poisoning/intoxication resulting from exposure to organophosphorus nerve agents.
c) The product must come in a self-contained single use autoinjector device capable of administering an intramuscular dose.
d) Each autoinjector must contain 2.1mg atropine and 600mg pralidoxime chloride.
e) All packaging of the product must be labelled in accordance with the direction of the approving regulatory agency.
f) The product must be manufactured in accordance with current Good Manufacturing Practices. Supplier must certify that the product has been manufactured in compliance with current Good Manufacturing Practices (cGMP).

3. Applicability of the trade agreement(s) to the procurement 

This requirement is subject to the Canadian Free Trade Agreement (CFTA), the Canada-Korea Free Trade Agreement, the Canada - Chile Free Trade Agreement (CCFTA), the Canada - Colombia Free Trade Agreement, the Canada - Honduras Free Trade Agreement, the Canada - Panama Free trade Agreement, the Canada - Peru Free Trade Agreement (CPFTA), the Canada - Ukraine Free Trade Agreement (CUFTA), the Canada -European Union Comprehensive Economic and Trade Agreement (CETA), the Canada - United Kingdom Trade Continuity Agreement (Canada-UK TCA), the Revised World Trade Organization Agreement on Government Procurement (WTO-AGP), and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

4. Justification for the Pre-Identified Supplier
Meridian Medical Technologies, Inc has been identified as the only authorized supplier able to supply an approved chemical nerve agent with atropine and pralidoxime chloride in a dual autoinjector format.

The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - “only one person or firm is capable of performing the contract”.

5. Period of the Contract

From award until March 31, 2025.

6. Name and address of the pre-identified supplier 

Meridian Medical Technologies, Inc.
6350 Stevens Forest Road, Suite 301
Columbia, MD 21046

7. Closing date for a submission of a statement of capabilities 

The closing date and time for accepting statements of capabilities is July 15, 2022 at 2:00pm EST.

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.