Poland – Pharmaceutical products – ZP/CZD/062/26 Supply of the investigational medicinal product ROMACICLIB (RVU 120) for use in the non-commercial MEDWAY clinical trial “A phase I study of the use of the CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive group 3 or 4 medulloblastoma”

Opportunity description

The subject of the contract is the supply of the investigational medicinal product ROMACICLIB (RVU 120) for use in the non-commercial MEDWAY clinical trial “A phase I study of the use of the CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive group 3 or 4 medulloblastoma” RVU120 25 mg capsules, 30 capsules per bottle RVU120 100 mg capsules, 30 capsules per bottle The subject of the contract is: 1. ROMACICLIB (RVU120) 25 mg x 30 capsules, labelled bottle 2. ROMACICLIB (RVU120) 100 mg x 30 capsules, labelled bottle The Contractor is obliged to deliver the subject of the contract in the following tranches: a) First tranche: RVU120 25 mg capsules, 30 capsules per bottle (211 bottles) RVU120 100 mg capsules, 30 capsules per bottle (421 bottles) b) Second tranche RVU120 25 mg capsules, 30 capsules per bottle (359 bottles) RVU120 100 mg capsules, 30 capsules per bottle (192 bottles) c) Extension of the second tranche* RVU120 25 mg capsules, 30 capsules per bottle (187 bottles) RVU120 100 mg capsules, 30 capsules per bottle (565 bottles) * The extension of the second tranche referred to in point c) above is not covered by funding under agreement No. 2024/ABM/02/00032 – 02 and is not included in the contract value specified in Annex No. 2. The terms for transferring the Goods from this extension — quantity, transfer for consideration or free of charge, manufacturing and delivery schedule, expiry date, and tax settlement — require the mutual decision of both Parties and will be specified in a separate agreement, provided that a prerequisite for the Parties’ decision to transfer the Goods covered by the extension is the prior submission by the Contracting Authority to the Medical Research Agency of a request to increase the funding awarded by the cost of manufacturing the quantity of Goods specified in point c). To minimise costs on the Contractor’s side, the extension may be ordered only as a single order jointly covering the second tranche in the full quantity specified in point b) above and the Goods covered by the extension (although it does not have to cover the full quantity of Goods specified in point c)), so that the Goods from the second tranche and the extension are manufactured as part of a single manufacturing process and delivered in a single shipment. Procedure: neg-wo-call. Estimated value: 3,071,506 PLN. Review the original TED notice for the complete requirement, lots, amendments and attachments.