Manufacture and Supply of HI-6 Dimethanesulfonate (DMS) Lyophilized Powder for Solution

Advance Contract Award Notice (ACAN)An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.Definition of the requirementThe Department of National Defence (DND) has a requirement for the manufacture and supply of HI-6 DMS drug product as a sterile lyophilized powder for solution to provide treatment from suspected exposure to chemical nerve agents. The requirement is for a single-use 20 mL vials at a concentration of 100 mg/mL after reconstitution with 10 mL of diluent or water for injection.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/equipment/system (as appropriate) meets the following requirements:3.1 The Bidder must demonstrate a minimum of one (1) year experience with the formulation, fill, finish and quality control of at least one (1) batch of HI-6 dimethanesuflonate (DMS) lyophilized powder for solution drug product within the last 15 years as of the closing date of this ACAN.3.1.1 The Bidder must provide the following information in order to demonstrate experience:The Client Name and Client Contact info (name, telephone number and email);The period of the experience (month/year to month/year); andA brief description of the experience working with the formulation, fill, finish and quality control of HI-6 dimethanesuflonate (DMS) lyophilized powder for solution drug product. 3.2 The Bidder must have implemented a pharmaceutical quality system (also known as a quality management system) that incorporates good manufacturing practices (GMP) and quality risk management of sufficient quality to comply with Part C, Division 2 of the Canadian Food and Drug Regulations.3.2.1 The Bidder must provide a high-level description of its quality management system and must provide the results of any GMP inspections executed by Health Canada, the United States Food & Drug Administration (FDA), and the European Medicines Agency (EMA) within the last 10 years as of the closing date of this ACAN.3.3 The Bidder must demonstrate a minimum of two (2) years of experience with the production of a small molecule sterile drug product of sufficient quality for a Phase I clinical trial within the last ten (10) years as of the closing date of this ACAN.3.3.1 The Bidder must provide the following information in order to demonstrate experience:a. The Client Name and Client Contact info (name, telephone number and email);b. The period of the experience (month/year to month/year); andA brief description of the experience working with the production of a small molecule sterile drug product of sufficient quality for a Phase I of a clinical trial.3.4 The Bidder’s person in charge of the Quality Control department:Educational qualifications and professional certifications/designations must be supported by copies of appropriate documentation (degree, diploma, or other verifiable proof).3.5 The Bidder must demonstrate that the proposed resource has a minimum of two (2) years of experience in practical training and experience as the head of Quality Control.3.5.1 The Bidder must provide the following information in order to demonstrate experience:a. The Client Name and Client Contact info (name, telephone number and email);b. The period of the experience (month/year to month/year); andc. A brief description of the experience in practical training and as the head of Quality Control.3.6 The Bidder must demonstrate that their proposed manufacturing premises has, at a minimum, all of the following:contain suitable/sufficient equipment;personnel for the formulation, andfill, finish, and quality control of HI-6 dimethanesuflonate (DMS) lyophilized powder for solution drug product.3.6.1 The Bidder must demonstrate that the above is in accordance with the requirements prescribed in Part C, Division 2 of the Canadian Food and Drug Regulations.3.7 The Bidder must have a minimum of two (2) years of experience in the preparation of Module 3 of the Common Technical Document (CTD) as prescribed by the International Council for Harmonization (ICH) within the last 10 years as of the closing date of this ACAN.3.7.1 The Bidder must provide the following information in order to demonstrate experience:The Client Name and Client Contact info (name, telephone number and email);The period of the experience (month/year to month/year); andA brief description of the experience working with the preparation of Module 3 of the Common Technical Document (CTD).4. Applicability of the trade agreements to the procurementThis procurement is subject to the following trade agreements:a. Canadian Free Trade Agreement (CFTA);b. Revised World Trade Organization - Agreement on Government Procurement (WTO-AGP);c. Canada-European Union Comprehensive Economic and Trade Agreement (CETA);d. Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP);e. Canada-Chile Free Trade Agreement (CCFTA);f. Canada-Colombia Free Trade Agreement;g. Canada-Honduras Free Trade Agreement;h. Canada-Korea Free Trade Agreement;i. Canada-Panama Free Trade Agreement;j. Canada-Peru Free Trade Agreement (CPFTA);k. Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA); andl. Canada-Ukraine Free Trade Agreement (CUFTA).5. Justification for the Pre-Identified SupplierKABS Laboratories Inc. is the pre-identified supplier because they have previously qualified and validated a number of the critical manufacturing processes and analytical assays to produce HI-6 DMS in vials through previously completed research, development and production.6. Government Contracts Regulations ExceptionThe following exception to the Government Contracts Regulations (GCRs) from http://laws-lois.justice.gc.ca/eng/regulations/SOR-87-402/page-2.html#h-6) is applicable:(c)  the nature of the work to be contracted is such that it would not be in the public interest to solicit bids.7. Exclusions and/or Limited Tendering ReasonsThe following exclusions and/or limited tendering reasons are invoked under the following trade agreements:Canadian Free Trade Agreement (CFTA) – Article 513 (1) (b) (iii): due to an absence of competition for technical reasons;World Trade Organization - Agreement on Government Procurement (WTO-AGP) – Article XIII (b) (iii): due to an absence of competition for technical reasons;Canada-European Union Comprehensive Economic and Trade Agreement (CETA) – Article XIII (b) (iii): due to an absence of competition for technical reasons;Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) – Article 15.10 (2) (b) (iii): due to an absence of competition for technical reasons;Canada-Chile Free Trade Agreement (CCFTA) – Article Kbis-16 (2) (c): necessary to protect intellectual property;Canada-Colombia Free Trade Agreement – Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons;Canada-Honduras Free Trade Agreement – Article 17.11 (2) (b) (iii): due to an absence of competition for technical reasons;Canada-Korea Free Trade Agreement – Article XIII (1) (b) (iii): due to an absence of competition for technical reasons;Canada-Panama Free Trade Agreement – Article 16.10 (1) (b) (iii): because of the absence of competition for technical reasons;Canada-Peru Free Trade Agreement (CPFTA) – Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons;Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) – refer to CETA as the provisions of CETA are incorporated by reference into and made part of this Agreement. (CETA) Article 19.12 (b) (iii); andCanada-Ukraine Free Trade Agreement (CUFTA) – Annex 10-6 (2) (a): any form of preference, including set asides, to benefit micro, small and medium enterprises.8. Ownership of Intellectual PropertyCanada intends to retain ownership of any Foreground Intellectual Property (IP) arising out of the proposed contract on the basis that the main purpose of the Contract is when the Contractor declares in writing that they are not interested in owning the Foreground IP.9. Period of the proposed contract or delivery dateThe proposed contract is from contract award to 31 March 2024, with the irrevocable option to extend the Contract for up to five (5) one-year option periods10. Cost estimate of the proposed contractThe estimated value of the Contract, including option periods is $5,400,000.00 CAD (Applicable Taxes extra).11. Name and address of the pre-identified supplier KABS Laboratories Inc. 4500 Tonnancour St-Hubert, Québec J3Y 9G212. Suppliers' right to submit a statement of capabilitiesSuppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN 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.13. Closing date for a submission of a statement of capabilitiesThe closing date and time for accepting statements of capabilities is November 18, 2022 at 02:00 P.M. EST.14. Inquiries and submission of statements of capabilities All inquiries must be submitted in writing to the Contracting Authority no later than five (5) calendar days before the closing date of the ACAN. Inquiries received after that time may not be answered.Inquiries and statements of capabilities are to be directed to:Name:  Natalie Provost, D Svcs C 3-4-3Title: Procurement and Contracting OfficerEmail:  Natalie.Provost@forces.gc.ca