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

Tender description

Appt. of a Contract Manufacturing Organisation for Production of DST-F to GMP 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 technical transfer of the research grade product from the current non-GMP provider. 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.