Technical Transfer of DST-F to CMO

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    "title": "Technical Transfer of DST-F to CMO",
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    "description": "This Contract is for Technology Transfer Services for DST-F manufacture from the Supplier's pilot scale facility to the appointed Contract Manufacturing Organisation (CMO). The Supplier currently manufactures the research-grade product. As the programme progresses towards Marketing Authorisation (MA) and commercial-scale manufacture, the DST-F production process must be Technically Transferred from The Suppliers pilot-scale facility to an appointed GMP-certified CMO.\nThe CMO has been appointed by means of a competitive flexible tender process, which is a separate requirement and contract to this Contract.\nTechnology Transfer is the collaborative process of moving scientific findings, intellectual property, and technical knowledge from creators to the CMO to develop commercial manufacturing. The process involves transferring data, designs, software, inventions, and expertise between organisations.\nThe Technology Transfer Services are necessary to: \n- Support knowledge transfer\n- Support documentation provision\n- Provide expert technical advice to enable the CMO to commence GMP manufacture\n- Support MA submission activities.",
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    "procurementMethodRationale": "Direct Award for the technical transfer from the pilot scale Supplier Lionex to the appointed Contract Manufacturing Organisation (CMO) under both Schedule 5, Condition 5 (a) and (b) and Condition 6 (a) and (b) of The Procurement Act 2023.\n5 The following conditions are met in relation to the public contract— \n(a) due to a particular supplier having intellectual property rights or other exclusive rights, only that supplier can supply the goods, services or works required, and \n(b)there are no reasonable alternatives to those goods, services or works. \n6 The following conditions are met in relation to the public contract— \n(a)due to an absence of competition for technical reasons, only a particular supplier can supply the goods, services or works required, and \n(b)there are no reasonable alternatives to those goods, services or works. \nThe explanations as to why the justification applies are as follows: \nThe Supplier has Intellectual Property Rights – Condition 5(a) APHA has an exclusive licence with Lionex for the current technology (IPR) for Diva Skin Test – Fusion (DST-F) production. \nAbsence of competition for technical reasons: Lionex have developed the DST‑F in partnership with APHA as the designated Pilot Scale provider. As a result, they hold the specialist knowledge, proprietary processes, and technical understanding required for its production and further development. No other supplier has been involved in the creation or pilot‑scale manufacture of DST‑F, and therefore no alternative provider has the capability or access to the necessary proprietary information to undertake the Technical Transfer to the CMO. For these reasons, Lionex are the only supplier in the market able to carry out the required work, demonstrating a clear absence of competition for technical reasons. \nNo reasonable alternatives: For the reasons outlined above, there are no reasonable alternatives in the market capable of delivering the Technical Transfer. No other supplier can complete the transfer to the newly appointed CMO, as they do not have the necessary knowledge, IPR or involvement in the development of DST‑F. Any alternative supplier would be required to redevelop a skin‑testing agent in collaboration with APHA, which would involve substantial time, resource investment, and a retendering of the CMO contract. This work cannot be delivered in‑house, as it requires specialist expertise that APHA does not have the capacity to provide. \nPre market engagement has not been carried out for this Technical Transfer requirement, as there is no other supplier in the market place who can deliver this service given the nature of the required services, however a UK05 & UK06 have been published, and the eight (8) day standstill period has been observed, to inform the market of this direct award without competition.",
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    "description": "This Contract seeks to acquire Technology Transfer Services for DST-F manufacture from the Supplier to the appointed CMO. The CMO has been appointed by means of a competitive flexible tender process, which is a separate requirement and contract to this Contract.\nTechnology Transfer is the collaborative process of moving scientific findings, intellectual property, and technical knowledge from creators to the CMO to develop commercial manufacturing. The process involves transferring data, designs, software, inventions, and expertise between organisations.",
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    "procurementMethodRationale": "Direct Award for the technical transfer from the pilot scale Supplier Lionex to the appointed Contract Manufacturing Organisation (CMO) under both Schedule 5, Condition 5 (a) and (b) and Condition 6 (a) and (b) of The Procurement Act 2023.\n5 The following conditions are met in relation to the public contract— \n(a) due to a particular supplier having intellectual property rights or other exclusive rights, only that supplier can supply the goods, services or works required, and \n(b)there are no reasonable alternatives to those goods, services or works. \n6 The following conditions are met in relation to the public contract— \n(a)due to an absence of competition for technical reasons, only a particular supplier can supply the goods, services or works required, and \n(b)there are no reasonable alternatives to those goods, services or works. \nThe explanations as to why the justification applies are as follows: \nThe Supplier has Intellectual Property Rights – Condition 5(a) APHA has an exclusive licence with Lionex for the current technology (IPR) for Diva Skin Test – Fusion (DST-F) production. \nAbsence of competition for technical reasons: Lionex have developed the DST‑F in partnership with APHA as the designated Pilot Scale provider. As a result, they hold the specialist knowledge, proprietary processes, and technical understanding required for its production and further development. No other supplier has been involved in the creation or pilot‑scale manufacture of DST‑F, and therefore no alternative provider has the capability or access to the necessary proprietary information to undertake the Technical Transfer to the CMO. For these reasons, Lionex are the only supplier in the market able to carry out the required work, demonstrating a clear absence of competition for technical reasons. \nNo reasonable alternatives: For the reasons outlined above, there are no reasonable alternatives in the market capable of delivering the Technical Transfer. No other supplier can complete the transfer to the newly appointed CMO, as they do not have the necessary knowledge, IPR or involvement in the development of DST‑F. Any alternative supplier would be required to redevelop a skin‑testing agent in collaboration with APHA, which would involve substantial time, resource investment, and a retendering of the CMO contract. This work cannot be delivered in‑house, as it requires specialist expertise that APHA does not have the capacity to provide. Pre market engagement has not been carried out for this Technical Transfer requirement, as there is no other supplier in the market place who can deliver this service given the nature of the required services, however a transparency notice will be published to inform the market of the intention to award this contract.",
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