6D024-203933/A - Anthrasil (6D024-203933/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:

EMERGENT BIOSOLUTIONS CANADA INC. 155 Innovation Drive Winnipeg Manitoba Canada R3T5Y3 Nature of Requirements:

1. Definition of the requirement

Public Services and Procurement Canada intends to establish a Contract with Emergent BioSolutions Inc. for Anthrasil (Anthrax Immune Globulin (Human) Injection) which is an antitoxin used to treat inhalation anthrax. Canada’s requirement is for the supply of up to approximately 17,000 units of Anthrasil.

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 toxemia associated with inhalational anthrax;

c) The anthrax antitoxin immune globulin must be polyclonal; d) The product must not require pre-dosing with medications (e.g., antihistamines, corticosteroids) to minimize the risk of infusion or hypersensitivity reactions;

e) Supplier must provide clinical data on use of the product in humans for treatment of anthrax; f) The bottles and all packaging of the product must be labelled in accordance with the direction from Health Canada; g) The product must have a minimum of five (5) years of shelf life from the date of manufacture of the final drug product ; h) The product must be manufactured in accordance with current Good Manufacturing Practices

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

This procurement is subject to the Canadian Free Trade Agreement(CFTA).

4. Justification for the Pre-Identified Supplier

This requirement is being negotiated with Emergent BioSolutions Inc. as they are the only known supplier capable of providing a polyclonal 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 March 31, 2022 with a 1 year option period.

6. Name and address of the pre-identified supplier

EMERGENT BIOSOLUTIONS CANADA INC. 155 Innovation Drive Winnipeg Manitoba Canada R3T5Y3

7. The closing date and time for accepting statements of capabilities is January 29th 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.