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 requirementDepartment of National Defence (DND), has a requirement for Calcium trisodium pentetate (Ca-DTPA) for the treatment of Canadian Armed Forces (CAF) members who may have been exposed to radiological warfare agents.The annual volume is estimated at approximately 250 Ca-DTPA ampoules per year.3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements).3.1 Any interested supplier must demonstrate by way of a statement of capabilities that their Calcium trisodium pentetate (Ca-DTPA) meets the following requirements:3.1.1 The Bidder must demonstrate that their proposed Calcium trisodium pentetate (Ca-DTPA) has the following Certification and Compliance:The Bidder must provide evidence that the product has been manufactured in compliance with current Good Manufacturing Practices (cGMP) as set out in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7–(https://database.ich.org/sites/default/files/Q7%20Gui…). The evidence provided must include, but is not limited to:a. The Certificate of Analysis representative of the batch or lot to be delivered. Certificates should be signed by the manufacturer’s Quality Assurance department; andb. Evidence of a successful cGMP compliance inspection within the last five (5) years from the regulatory national competent authority from Canada, the United States, the United Kingdom, or a member state of the European Union or any other regulatory jurisdiction which has adopted and implemented the International Conference for Harmonisation (ICH) guidances and standards.Proof of GMP must be provided.3.1.2 The Bidder must demonstrate by providing an executed Certificate of Analysis from a lot representative of the material to be delivered that their proposed Calcium trisodium pentetate (Ca-DTPA) contains the following drug type and potency:Drug Product (Ca-DTPA)Active ingredient : Calcium trisodium pentetateDose : 1000 to 1055 mgVolume : 5.0 mLDosage Form: Solution for injectionThe primary packaging must include:the product name;strength;lot/batch number; andexpiry date or date of manufacture.Route of administration : IntravenousPhysicochemical characteristics : Free from undissolved materials or particulates, clear, colourless to slightly yellowish solution.Sterility: Sterile3.1.3 The Bidder must demonstrate that the drug insert and packaging information of their proposed Calcium trisodium pentetate (Ca-DTPA) are in English or French. A copy of the package insert, product labelling and a picture of the product must be provided.3.1.4 The Bidder must demonstrate by providing real-time stability data that their proposed Calcium trisodium pentetate (Ca-DTPA) has a minimum shelf life of 36 months at 15 - 25°C from the date of manufacture.3.1.5 The Bidder must demonstrate with a photo or design mock-up of the primary package label thattheir proposed Calcium trisodium pentetate (Ca-DTPA) has the following information included on its primary package label:LabellingThe primary packaging must include:the product name;strength,;lot/batch number; andexpiry date or date of manufacture.4. Applicability of the trade agreement(s) to the procurementThis procurement is subject to the following trade agreement(s):Canadian Free Trade Agreement (CFTA);Canada-Chile Free Trade Agreement (CCFTA);Canada-Colombia Free Trade Agreement;Canada-Honduras Free Trade Agreement;Canada-Korea Free Trade Agreement; andCanada-Panama Free Trade Agreement.5. Justification for the Pre-Identified SupplierHeyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG, the pre-identified supplier, is the only known supplier that can provide the Calcium Trisodium Pentetate (Ca-DTPA).6. Government Contracts Regulations ExceptionThe following exception to Government Contracts Regulations (GCRs) from http://laws-lois.justice.gc.ca/eng/regulations/SOR-87…) is applicable:(d) only one person is capable of performing the contract.7. Exclusions and/or Limited Tendering ReasonsCanadian Free Trade Agreement (CFTA) – Article 513 (1) (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; andCanada-Panama Free Trade Agreement – Article 16.10 (1) (b) (iii): because of the absence of competition for technical reasons.8. Period of the proposed contract or delivery dateThe proposed Contract period is from date of Contract award to 31 March 2026.9. Cost estimate of the proposed contractThe estimated value of the contract, including options, is $120,000.00 (taxes not applicable)10. Name and address of the pre-identified supplier?Name: Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KGAddress: Kurfürstendamm 178 - 179, 10707 Berlin, Germany11. 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 01 June 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: M••••••••@••••••.••.ca
