Anthrax Antitoxin-Anthim

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: 
Elusys Therapeutics, Incorporated
4 Century Drive, Suite 260
Parsippany New Jersey
United States
07054
Nature of Requirements: 

1. Definition of the requirement 
Public Services and Procurement Canada intends to establish a Contract with Elusys Therapeutics for Anthim (oblitoxaximab Injection) which is an antitoxin used to treat inhalation anthrax.

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 it meets the following requirements:
a) The product must have regulatory approval from Health Canada (HC);
b) The product must be indicated by Health Canada for the treatment of adult and pediatric patients with inhalational anthrax in combination with antibacterial drugs, and for post exposure prophylaxis on inhalation anthrax when alternative therapies  are not available or appropriate. 
c) The anthrax antitoxin must be a monoclonal antibody for protection against Bacillus anthracis;
d) The bottles and all packaging of the product must be labelled in accordance with the direction from Health Canada;
e) The product must have a minimum of seven years (7) years of shelf life from the date of manufacture of the final drug product ;
f) The product must be manufactured in accordance with current Good Manufacturing Practices
g) Must be able to deliver finished product by no later than September 2022.

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

4. Justification for the Pre-Identified Supplier 
This requirement is being negotiated with Elusys Therapeutics as they are the only known supplier capable of providing a monoclonal antibody treatment for inhalation anthrax. 
The following exception(s) to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) only one person is capable of performing the work.

5. Period of the Contract
From contract award to until all deliverables are received.

6. Name and address of the pre-identified supplier 
Elusys Therapeutics, Inc.
4 Century Drive, Suite 260
Parsippany, NJ 
USA 07054

7. The closing date and time for accepting statements of capabilities is April 1,2022 at 2:00pm.

8. Inquiries and statements of capabilities are to be directed to:

TPSGC.Vaccin-Vaccine.PWGSC@tpsgc-pwgsc.gc.ca

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.