Vaccinia immunoglobulin

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: 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 vaccinia immunoglobulin intravenous (Human) (VIGIV) to protect against complications from vaccination with live-replicating smallpox vaccines containing vaccinia virus. Canada has a requirement for up to approximately 6,000 vials of VIG (2,000 vials by March 31, 2022).

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 be approved by HC with an indication for the treatment and/or modification of the following conditions: i. eczema vaccinatum; ii. progressive vaccinia; iii. severe generalized vaccinia; iv. vaccinia infections in persons with certain skin conditions (such as burns, impetigo, varicella zoster or poison ivy); or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions; v. aberrant infections induced by vaccinia virus including accidental implantation in the eyes (with the exception of cases of isolated keratitis), mouth or other areas where vaccinia infection would constitute a special hazard. c) The product must have an indication for prophylaxis of patients with skin conditions that may predispose individuals for the development of eczema vaccinatum, progressive or generalized vaccinia. d) Product must have a minimum of five (5) years of shelf life from the date of manufacture of the final drug product; e) Product must have a minimum of four (4) years of shelf life remaining at the time of delivery to destination; f) Product must have a storage temperature less than or equal to -15°C. g) The vials and all packaging of the product must be labelled in accordance with the direction from Health Canada; h) The product must be manufactured in accordance with current Good Manufacturing Practices.

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

The requirement 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 Emergent BioSolutions Inc. as they are the only known supplier capable of providing vaccinia immunoglobulin intravenous (Human) (VIGIV). 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, 2024.

6. Name and address of the pre-identified supplier

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

7. Closing date for submitting statements of capabilities

The closing date and time for accepting statements of capabilities is December 23rd, 2021 at 2:00pm. .

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

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

Delivery Date: 30/11/2021

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.