Appointment of a Contract Manufacturing Organisation for Production of DST-F to GMP Standards

{
  "buyer": {
    "id": "GB-PPON-PBHC-6261-BLLQ",
    "name": "ANIMAL AND PLANT HEALTH AGENCY"
  },
  "date": "2025-11-10T15:17:32Z",
  "id": "072500-2025",
  "initiationType": "tender",
  "language": "en",
  "ocid": "ocds-h6vhtk-052ac4",
  "parties": [
    {
      "address": {
        "country": "GB",
        "countryName": "United Kingdom",
        "locality": "London",
        "postalCode": "SW1P 4DF",
        "region": "UKI32",
        "streetAddress": "Seacole Building, 2 Marsham Street"
      },
      "contactPoint": {
        "email": "olubunmi.akinmade@defra.gov.uk",
        "name": "Olubunmi Akinmade"
      },
      "details": {
        "classifications": [
          {
            "description": "Public authority - central government",
            "id": "publicAuthorityCentralGovernment",
            "scheme": "UK_CA_TYPE"
          }
        ],
        "url": "https://defra-family.force.com/s/Welcome"
      },
      "id": "GB-PPON-PBHC-6261-BLLQ",
      "identifier": {
        "id": "PBHC-6261-BLLQ",
        "scheme": "GB-PPON"
      },
      "name": "ANIMAL AND PLANT HEALTH AGENCY",
      "roles": [
        "buyer"
      ]
    }
  ],
  "tag": [
    "tender"
  ],
  "tender": {
    "aboveThreshold": true,
    "awardPeriod": {
      "endDate": "2026-04-01T23:59:59+01:00"
    },
    "coveredBy": [
      "GPA",
      "CPTPP"
    ],
    "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, undertake the scaled up production and supply of the DST-F reagent, a diagnostic skin test to Detect Infected among Vaccinated Animals (DIVA). This will involve the technology transfer of the research grade fusion protein-based reagent from the current ISO-accredited provider.",
    "documents": [
      {
        "documentType": "conflictOfInterest",
        "id": "conflictOfInterest"
      },
      {
        "datePublished": "2025-11-10T15:17:32Z",
        "description": "Tender notice on Find a Tender",
        "documentType": "tenderNotice",
        "format": "text/html",
        "id": "072500-2025",
        "noticeType": "UK4",
        "url": "https://www.find-tender.service.gov.uk/Notice/072500-2025"
      }
    ],
    "enquiryPeriod": {
      "endDate": "2025-12-15T12:00:00Z"
    },
    "id": "C30459",
    "items": [
      {
        "additionalClassifications": [
          {
            "description": "Vaccines for veterinary medicine",
            "id": "33651690",
            "scheme": "CPV"
          },
          {
            "description": "Pharmaceutical products",
            "id": "33600000",
            "scheme": "CPV"
          }
        ],
        "deliveryAddresses": [
          {
            "country": "GB",
            "countryName": "United Kingdom",
            "region": "UK"
          }
        ],
        "id": "1",
        "relatedLot": "1"
      }
    ],
    "legalBasis": {
      "id": "2023/54",
      "scheme": "UKPGA",
      "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents"
    },
    "lotDetails": {
      "noLotsDivisionRationale": "Dividing the contract into separate lots has been considered not feasible due to the highly integrated nature of the required services, which include technology transfer, manufacturing, production of consistency batches, quality assurance and control, and regulatory support during the Marketing Authorisation submission process. Fragmentation would introduce significant coordination challenges, increase the risk of quality inconsistency, and complicate the management of interdependent activities. A single-source award is commercially more attractive, offering streamlined delivery, operational efficiency, and clear accountability across all stages of product development and supply."
    },
    "lots": [
      {
        "awardCriteria": {
          "criteria": [
            {
              "description": "As set out in the Bidder Pack.",
              "name": "Technical",
              "numbers": [
                {
                  "number": 70.0,
                  "weight": "percentageExact"
                }
              ],
              "type": "quality"
            },
            {
              "description": "As set out in the Bidder Pack.",
              "name": "Commercial",
              "numbers": [
                {
                  "number": 30.0,
                  "weight": "percentageExact"
                }
              ],
              "type": "price"
            }
          ]
        },
        "contractPeriod": {
          "endDate": "2033-04-19T23:59:59+01:00",
          "maxExtentDate": "2037-04-19T23:59:59+01:00",
          "startDate": "2026-04-20T00:00:00+01:00"
        },
        "hasOptions": true,
        "hasRenewal": true,
        "id": "1",
        "options": {
          "description": "The Contracting Authority may, at its sole discretion, exercise one or more of the following options during the term of the Contract:\n- Grant a commercial licensing agreement to the                      successful Supplier for the manufacture and \nsupply of DST-F to Rest of World (RoW) markets, \nsubject to separate agreement and regulatory approvals.\n- Expand the scope of services to include support for additional Marketing Authorisation applications outside Great Britain.\n- Increase the volume of DST-F doses required, subject to policy changes and budget availability.\nThese options are provided for in the original procurement and shall be exercised only where they do not substantially alter the nature of the Contract.\nThe Supplier shall be notified in writing of the Authority\u2019s intention to exercise any option, and the parties shall agree any contract variations"
        },
        "renewal": {
          "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.\nAny extension shall be exercised by giving the Supplier no less than six (6) months\u2019 written notice prior to the expiry of the initial term.\nAll terms and conditions shall remain unchanged during the extension period unless otherwise agreed in writing."
        },
        "selectionCriteria": {
          "criteria": [
            {
              "description": "As set out in the Bidder Pack.",
              "type": "economic"
            },
            {
              "description": "As set out in the Bidder Pack.",
              "type": "technical"
            }
          ]
        },
        "status": "active",
        "suitability": {
          "sme": true
        },
        "value": {
          "amount": 9786429.0,
          "amountGross": 11999998.8,
          "currency": "GBP"
        }
      }
    ],
    "mainProcurementCategory": "goods",
    "procedure": {
      "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\u2019s eSourcing system.\nAs outlined in \u0027Part 2 \u2013 Procurement Specific Requirements of the Bidder Pack\u0027, the Authority reserves the right to conduct negotiations with all participating Tenderers following the completion of Stage 1 \u2013 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.\n Important Notice to Tenderers\nInitial 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.\nStage 1 \u2013 Initial Tender Stage\n1. Procurement Specific Questionnaire- \nTenderers 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.\n2. Conditions of Participation - \nResponses 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.\n3. Tender Evaluation - \nAll compliant tenders will be evaluated in accordance with the scoring methodology detailed in this document and within the Authority\u2019s eSourcing platform.\nStage 2 \u2013 Negotiation Stage (Optional)\nIf the Authority elects to proceed with negotiations:\n\u2022 Tenderers will receive Initial Assessment Summaries, providing high-level feedback on their submissions.\n\u2022 The Authority will issue negotiation details and agenda.\n\u2022 Negotiations will be strictly limited to the topics specified in the Bidder Pack.\nStage 3 \u2013 Final Tender Stage\n1. Invitation to Submit Final Tenders -\nFollowing the conclusion of negotiations, Tenderers will be invited to submit their Final Tenders.\n2. Clarification Period -\nA five (5) working day window from date of Invitation to Submit Final Tender will be provided for written clarification questions via Atamis.\n3. Final Submission Window - \nTenderers will have fourteen (14) working days to resubmit their final tender via Atamis.\n4. Final Evaluation - \nFinal tenders will be evaluated using the same Award Criteria. \nTechnical and commercial scores will be combined to determine the Most Advantageous Tender.\nTie-Breaker Procedure - \nIn 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; \n1) The Tenderer who gained the higher score for E01 \u2018GMP Compliance\u2019 will be awarded the contract. \n2) If the tie still endures after step 1 the Tenderer who gained the higher commercial score will be awarded the contract."
    },
    "procurementMethod": "open",
    "procurementMethodDetails": "Competitive flexible procedure",
    "riskDetails": "Regulatory Risks \n1) Marketing Authorisation Refusal for the Cattle BCG Vaccine;\nThe 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.\nLikelihood: Medium\nThis may result in the deployment of DST-F being significantly delayed or no longer required. \n2) Marketing Authorisation Refusal for DST-F reagent;\nRisk that the Marketing Authorisation  is refused \nLikelihood: Medium\nThis could impact contract viability and deployment timelines .\nPolicy and Political Risks\n1) Change in TB policy during contract term\nLikelihood: Low\nThis may affect DST-F demand and contract scope\n2) Impact of Government Spending Review (2026/27 onwards)\nLikelihood: Medium\nThis could affect affordability and budget availability\n3) Farm Trial Specificity Below Expectations\n1) 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. \nLikelihood: Low\nThis could affect the contract deployment timelines.",
    "status": "active",
    "submissionMethodDetails": "The procurement documents are available for unrestricted and full direct access, free of charge, at https://defra-family.force.com/s/Welcome\nAny questions, requests to participate or tender submissions must be submitted electronically via this portal.\nIf you need technical help with the Atamis system, either when registering, or when completing a tender, please contact the Atamis support team e-mail Support@Atamis.co.uk or phone Tel: 029 2279 0052.",
    "submissionTerms": {
      "electronicSubmissionPolicy": "allowed",
      "languages": [
        "en"
      ]
    },
    "tenderPeriod": {
      "endDate": "2025-12-15T12:00:00Z"
    },
    "title": "Appointment of a Contract Manufacturing Organisation for Production of DST-F to GMP Standards",
    "value": {
      "amount": 9786429.0,
      "amountGross": 11999998.8,
      "currency": "GBP"
    }
  }
}