Appt. of a Contract Manufacturing Organisation for Production of DST-F to GMP

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                "description": "Department of Environment, Food and Rural Affairs (Defra) on behalf of Animal and Plant Health Agency (APHA) wishes to inform potential suppliers of an upcoming procurement opportunity and to invite them to participate in early market engagement. The market engagement will consist of; 1. virtual Supplier Briefing Presentation, 2. the issuance of Information pack and Market Engagement Questionnaire (MEQ) and 3. 1:1 Supplier Feedback Sessions to discuss the information provided in the MEQ and further understand supplier capabilities with regard to this requirement. It is important to note that this is not a call for competition. Overview of Requirements: Defra is seeking to appoint a Contract Manufacturing Organisation who will work in partnership with the Authority to achieve UK Marketing Authorisation of the Diva Skin Test - Fusion (DST-F) and, thereafter scale up production for its supply. The services will include: * Technical transfer of the DST-F product * Production of consistency batches * Support the Authority's Marketing Authorisation submission * Commercial manufacture and supply of DST-F to UK upon successfully obtaining Marketing Authorisation * Prospective supply to rest of the world, subject to relevant marketing authorisations being achieved Supplier Briefing Presentation: We now invite potential suppliers to a briefing presentation, where we will provide a detailed overview of our requirements and the intended procurement process. This event will be an opportunity for suppliers to gain a better understanding of our needs and to engage with our team. Date: Friday 27th of June 2025 Time: 10:00am Location: Virtual Meeting via the Microsoft Teams Platform How to Participate: Interested suppliers are invited to register their interest in this opportunity via email to: Olubunmi.Akinmade@defra.gov.uk using the email title, 'Contract Manufacturing Organisation for Production of DST-F to GMP Standards - Interested Supplier'. Upon registration, suppliers will receive further details about the Supplier Briefing Presentation Day. Please include the following information in your email: * Company name * Contact details - email address, preferred person to contact, role or position in company, telephone number * Confirm whether you are a GMP manufacturer or not Information Pack and Market Engagement Questionnaire (MEQ): Shortly following the Supplier Briefing Presentation, we will issue an Information document and a Market Engagement Questionnaire to suppliers that registered interest. The purpose of this is to provide suppliers with the information of the upcoming procurement opportunity and invite them to: * Provide feedback on Scope/Requirements * Provide feedback on the Commercial approach * Provide feedback on the proposed Terms and Conditions * Provide input into the procurement process Please note due to the sensitive nature of the requirement, all interested suppliers will be required to sign and return an Authority provided Non-Disclosure Agreement in order to participate. The documents are designed to gather valuable input from interested suppliers to inform our procurement strategy and requirements. Timeline: * Early Market Engagement Publication: Friday 6th June 2025 * Registration Deadline: 3pm on Tuesday 24th June 2025 * Supplier Briefing Presentation: Friday 27th June 2025 * Information Pack and MEQ Issuance: Monday 30th June 2025 * MEQ Submission Deadline: 3pm Monday 14th July 2025 * 1:1 Supplier Feedback Sessions: Wednesday 16th July 2025 Contact Information: For any queries related to this procurement, please contact: Name: Olubunmi Akinmade Position: Senior Commercial Officer Email: Olubunmi.akinmad@defra.gov.uk Thank you for your interest.",
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        "title": "Appt. of a Contract Manufacturing Organisation for Production of DST-F to GMP",
        "description": "A Contract Manufacturing Organisation (CMO) certified to EU Good Manufacturing Practice (GMP) standards is required to work in partnership with the Authority to achieve UK Marketing Authorisation (MA) and, thereafter, for scaled up production of the DST-F product, a diagnostic skin test to Detect Infected among Vaccinated Animals (DIVA). This will involve the technology transfer of the research grade product from the current non-GMP provider and the production of consistency batches.",
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                    "description": "The Contracting Authority reserves the right to extend the Contract by up to twenty-four (24) months, in increments of twelve (12) months, subject to satisfactory performance and continued operational need. Any extension shall be exercised by giving the Supplier no less than six (6) months' written notice prior to the expiry of the initial term. All terms and conditions shall remain unchanged during the extension period unless otherwise agreed in writing."
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                    "description": "The Contracting Authority may, at its sole discretion, exercise one or more of the following options during the term of the Contract: - Grant a commercial licensing agreement to the successful Supplier for the manufacture and supply of DST-F to Rest of World (RoW) markets, subject to separate agreement and regulatory approvals. - Expand the scope of services to include support for additional Marketing Authorisation applications outside Great Britain. - Increase the volume of DST-F doses required, subject to policy changes and budget availability. These options are provided for in the original procurement and shall be exercised only where they do not substantially alter the nature of the Contract. The Supplier shall be notified in writing of the Authority's intention to exercise any option, and the parties shall agree any contract variations"
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            "features": "This procurement is being conducted as a Competitive Flexible Procedure in accordance with the Procurement Act 2023. Completion and submission of all documents will be conducted via the Authority's eSourcing system. As outlined in 'Part 2 - Procurement Specific Requirements of the Bidder Pack', the Authority reserves the right to conduct negotiations with all participating Tenderers following the completion of Stage 1 - Initial Tender Evaluation. However, Tenderers are strongly advised not to rely on the optional negotiation phase to clarify or introduce critical elements of their submission. Important Notice to Tenderers Initial tender submissions must be clear, complete, and comprehensive, including all relevant information, assumptions, and pricing. The Authority may choose not to proceed to the negotiation stage, and therefore, Tenderers should submit their best possible offer in the first instance. Stage 1 - Initial Tender Stage 1. Procurement Specific Questionnaire- Tenderers must complete a set of questions to enable the Authority to verify core supplier information, exclusions, and debarment status. Responses will be assessed to ensure compliance with all mandatory and discretionary requirements. 2. Conditions of Participation - Responses will be evaluated to confirm that Tenderers meet the minimum capability thresholds. Tenderers failing to meet the minimum capability requirement will be excluded from the procurement process. 3. Tender Evaluation - All compliant tenders will be evaluated in accordance with the scoring methodology detailed in this document and within the Authority's eSourcing platform. Stage 2 - Negotiation Stage (Optional) If the Authority elects to proceed with negotiations: * Tenderers will receive Initial Assessment Summaries, providing high-level feedback on their submissions. * The Authority will issue negotiation details and agenda. * Negotiations will be strictly limited to the topics specified in the Bidder Pack. Stage 3 - Final Tender Stage 1. Invitation to Submit Final Tenders - Following the conclusion of negotiations, Tenderers will be invited to submit their Final Tenders. 2. Clarification Period - A five (5) working day window from date of Invitation to Submit Final Tender will be provided for written clarification questions via Atamis. 3. Final Submission Window - Tenderers will have fourteen (14) working days to resubmit their final tender via Atamis. 4. Final Evaluation - Final tenders will be evaluated using the same Award Criteria. Technical and commercial scores will be combined to determine the Most Advantageous Tender. Tie-Breaker Procedure - In the event of a tie in total scores following evaluation of the Final Tenders, the Authority will apply a tie-breaker to award the contract. This process will only apply to the Tenderers who have the highest overall scoring tenders and will be applied in this listed order; 1) The Tenderer who gained the higher score for E01 'GMP Compliance' will be awarded the contract. 2) If the tie still endures after step 1 the Tenderer who gained the higher commercial score will be awarded the contract."
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        "riskDetails": "Regulatory Risks 1) Marketing Authorisation Refusal for the Cattle BCG Vaccine; The Contracting Authority has submitted a Marketing Authorisation (MA) application to the Veterinary Medicines Directorate for the Cattle BCG Vaccine, which is complementary to the DST-F reagent. Likelihood: Medium This may result in the deployment of DST-F being significantly delayed or no longer required. 2) Marketing Authorisation Refusal for DST-F reagent; Risk that the Marketing Authorisation is refused Likelihood: Medium This could impact contract viability and deployment timelines . Policy and Political Risks 1) Change in TB policy during contract term Likelihood: Low This may affect DST-F demand and contract scope 2) Impact of Government Spending Review (2026/27 onwards) Likelihood: Medium This could affect affordability and budget availability 3) Farm Trial Specificity Below Expectations 1) Farm trials may indicate that product specificity is lower than expected. This would not constitute trial failure, but significantly low specificity would require the Authority to undertake a model reassessment and root cause analysis. Likelihood: Low This could affect the contract deployment timelines.",
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                }
            ]
        }
    ]
}