Atropine Sulfate Autoinjectors and Training Devices

1. 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.2. Definition of the requirementThe Department of National Defence has a requirement for the supply of Atropine Sulfate autoinjectors to provide treatment of intoxication resulting from suspected exposure to chemical nerve agents, and an associated re-usable training device to train users on the safe handling and use of the device.The initial requirement is for 200 multi-use Atropine autoinjector training devices to be delivered 180 days after contract award and no later than 31 March 2023, including optional requirements to procure up to 3,000 Atropine Sulfate Autoinjectors and up to 500 multi-use Atropine Autoinjector training devices as and when requested during the period of the contract.3. 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 with an executed Certificate of Analysis from a lot representative of the material to be delivered that they proposed Atropine Sulfate autoinjector contains 2.0 mg (or 1.67 mg atropine base).3.2 The Bidder must demonstrate that their proposed Atropine Sulfate autoinjector has the following information included on its primary package label:• Product name• Strength• Lot or batch number• Expiry date or date of manufactureA photo or design mock-up of the primary package label must be provided as part of their bid.3.3 The Bidder must demonstrate that their proposed Atropine Sulfate autoinjector has a minimum shelf-life of 24 months from date of manufacture.Real-time stability data for a minimum of 24 months at 15 - 25°C must be provided as part of their bid.3.4 The Bidder must demonstrate that their proposed Atropine Sulfate autoinjector is approved by Health Canada, the United States Food and Drug Administration (FDA), or the European Medicines Agency.A copy of the most recently approved prescribing information must be provided as part of their bid.3.5 The Atropine autoinjector training device must be the same size and shape as the Atropine Sulfate autoinjector.A photo or design mock-up must be provided as part of their bid.3.6 The Atropine autoinjector training device must be capable of being reset to facilitate multiple uses in a training environmentInstructions on how to reset the training device must be provided as part of their bid.4. Applicability of the trade agreement(s) to the procurementThis procurement is subject to the following trade agreement(s):Canadian Free Trade Agreement (CFTA);Revised World Trade Organization - Agreement on Government Procurement (WTO-AGP);Canada-European Union Comprehensive Economic and Trade Agreement (CETA);Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP);Canada-Chile Free Trade Agreement (CCFTA);Canada-Colombia Free Trade Agreement;Canada-Honduras Free Trade Agreement;Canada-Korea Free Trade Agreement;Canada-Panama Free Trade Agreement;Canada-Peru Free Trade Agreement (CPFTA);Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA); andCanada-Ukraine Free Trade Agreement (CUFTA).5. Justification for the Pre-Identified SupplierRafa Laboratories Limited, the pre-identified supplier, is the only known supplier that can provide Atropine Sulfate autoinjectors and multi-use autoinjector training devices.6. Government Contracts Regulations Exception(s)The following exception to Government Contracts Regulations (GCRs) from http://laws-lois.justice.gc.ca/eng/regulations/SOR-87-402/page-2.html#h-6) is applicable:(d) only one person is capable of performing the contract.7. Exclusions and/or Limited Tendering ReasonsThe following exclusion(s) 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 – referencing the WTO Protocol Amending the GPA, 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-Ukraine Free Trade Agreement (CUFTA) – Annex 10-6 (2) (a): any form of preference, including set asides, to benefit micro, small and medium enterprises; andCanada-United Kingdom Trade Continuity Agreement: 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).8. Period of the proposed contract or delivery dateThe proposed contract is from contract award to 31 March 2027.9. Cost estimate of the proposed contractThe estimated value of the contract, including option(s), is $404,100.00 (GST/HST extra).10. Name and address of the pre-identified supplierRafa Laboratories Limited5 Shlomo (momo) HaveliJerusalem, 9777019Isarel11. Suppliers' right to submit a statement of capabilitiesSuppliers who consider themselves fully qualified and available to provide the goods 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.12. Closing date for a submission of a statement of capabilitiesThe closing date and time for accepting statements of capabilities is September 12, 2022 at 2:00 p.m. EDT.13. 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: Marie-Diane PayeurTitle: Senior Procurement OfficerE-mail: Marie-Diane.Payeur@forces.gc.ca