{"status":"OK","data":{"advertisement":{"id":356667,"title":"\u201eEvaluation of the Safety, Efficacy, and Dose Optimization of Intra-Articular Allocetra Administration in Adult Participants with Symptomatic Primary Age-Related Knee Osteoarthritis\u201d","partial_offer_allowed":false,"publication_date":"2026-03-20","submission_deadline":"2026-03-26 23:59:59","planned_sign_date":null,"supplementary_orders":null,"terms_of_contract_change":"The Ordering Party reserves the right to change the terms of the contract concluded as a result of these\nproceedings:\na. in the event of a change in applicable regulations, if it is necessary to adapt the content of the Agreement\nto the current legal status (including applicable standards),\nb. where the need for amendment is a consequence of amendments to guidelines, recommendations or\ndecisions issued by the institution which granted the appropriations to finance the Agreement,\nc. in the event of a change in the rate of tax on goods for the assortment being the subject of the Agreement,\nd. term of the contract \u2013 the Ordering Party reserves the right to change the expected date of the contract\nfollowing changes in the scope of the signed agreement for co-financing the Project(s) (extension of the\nduration of the Project(s) or relevant stages of the Project(s),\ne. when the changes concern the provision of additional services not covered by the basic contract\n(supplementary orders), the value of the changes will not exceed 50% of the contract value originally\nspecified in the contract;\nf. occurrence of force majeure - the Ordering Party reserves the right to change the terms of the contract\nconcluded as a result of these proceedings also in the event of force majeure understood as an event that\nfundamentally hinders the performance of obligations under the co-financing agreement, which the parties\ncould not foresee and prevent, as well as overcome through due diligence.\ng. in the case of conditions in accordance with Chapter 3.2.4. point 4 points b to e of the Guidelines on\neligibility of expenditure for the years 2021-2027.","created_at":"2026-03-20 19:12:54","modified_at":"2026-03-27 00:00:56","contact_persons":[{"id":114154,"forename":"Ankri","surname":"Chen","phone_number":"972 54 211 1356","email":"chen@enlivex.com","created_by":null,"created_at":"2026-03-26 14:38:50","modified_at":"2026-03-26 14:38:50","modified_by":null}],"orders":[{"id":576775,"estimated_value":null,"order_items":[{"id":649606,"description":"ANNOUNCEMENT DATED MARCH 20, 2026\nWe would like to inform you that the content of the request for proposals has been updated.\n\nIn connection with the implementation of project(s) entitled \"Evaluation of the Safety, Efficacy, and Dose Optimization of Intra-Articular Allocetra Administration in Adult Participants with Symptomatic Primary Age-Related Knee Osteoarthritis\u201d applying for funding in the call no. FENG.01.01-IP.02-001/26  under the European Funds for Smart Economy program and in connection with the obligation to make purchases based on the most economically advantageous offer, observing the principles of fair competition, efficiency, openness and transparency, ENLIVEX POLAND submits an inquiry regarding the implementation of  Research services. \n\nSCOPE OF THE WORK: \nPhaseV will support Enlivex Poland in the analysis of an additional cohort of patients that should be added to the Customer\u2019s Phase 2b OA trial (ENX-CL-05-002)\nMethodology & Deliverables\nThe scope of work may include, inter alia, the following components; provided, however, that such components are non-exhaustive and shall be further discussed and agreed between the Parties in accordance with Section 1 (condition precedent) set forth above.\nPre- Study execution services:\n \n1. Study design:\n\u25cf Develop randomization and stratification strategy with statistical justification\n\u25cf Define study population and sample size requirements with appropriate statistical assumptions\n\u25cf Conduct comprehensive power analysis and sample size calculations, including sensitivity analyses, aligned with study objectives, design, and endpoint\n \n2. Trial Synopsis\n\u25cf Prepare a synopsis for the selected trial design, summarizing key elements, procedures, and an initial feasibility assessment to support future regulatory submission\n\u25cf Draft statistical sections for the synopsis or protocol, including statistical \u00a9 Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only\njustification documents for novel design elements or analytical approaches\n \n3. Statistical Analysis Plan (SAP) Development\n\u25cf Develop a detailed SAP covering all primary and secondary analyses\n\u25cf Define analysis populations (intent-to-treat, per-protocol, safety) with clear statistical rationale\n\u25cf Specify statistical methods and models appropriate for the study design and endpoints\n\u25cf Incorporate advanced statistical modeling, including missing data handling and subgroup analysis plans.\n4. Advisory Support\n\u25cf Provide ongoing support for trial design discussions with FDA, EMA, and other regulators\n\u25cf Address regulator questions and feedback, supplying materials and responses to support the design\n \n5. Protocol review\n \nBIOSTATISTICS\n\u25cf CRF Review\n\u25cf Randomization schedule (list)\n\u25cf TLF Shells Unique\n\u25cf TLF Shells Repeat\n\u25cf Biostatistics Data Review Meetings\n\u25cf CSR Review\n \nSDTM\n\u25cf SDTM Annotated CRF\n\u25cf SDTM Dataset Programming\n\u25cf SDTM Programming (External Vendors)\n\u25cf SDTM cSDRG\n\u25cf SDTM Define.xml\n\u25cf SDTM Oversight and Review \u00a9 Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only\n \n \nADaM\n\u25cf ADaM Specification\n\u25cf ADaM Dataset Programming\n\u25cf ADRG\n\u25cf ADaM Define.xml\n\u25cf ADaM Oversight and Review\n \nOUTPUT DEVELOPMENT\n\u25cf Tables Unique\n\u25cf Tables Repeat\n\u25cf Listings\n\u25cf TLF Oversight and Review\n \nSUBMISSION PACKAGE\n\u25cf SDTM Submission Package\n\u25cf ADaM Submission Package\n \nDSMB\n\u25cf DSMB: Derived Datasets\n\u25cf DSMB: Tables Unique\n\u25cf DSMB: Listings\n\u25cf DSMB Datasets Rerun (Unblinded)\n\u25cf DSMB Output Rerun (Unblinded)\n\u25cf Prepare DSMB Report (Unblinded)\n\u25cf DSMB Meeting Participation\n\u25cf DSMB Oversight and Review\n\u25cf DSMB Subsequent Derived Datasets Rerun (Blinded)\n\u25cf DSMB Subsequent Output Rerun (Blinded)\n\u25cf DSMB Subsequent Datasets Rerun (Unblinded) \u25cf DSMB Subsequent Output Rerun (Unblinded)\n\u25cf Prepare DSMB Subsequent Report (Unblinded)\n\u25cf DSMB Subsequent Meeting Participation\n\u25cf DSMB Subsequent Oversight and Review\n \nDRY RUN\n\u25cf SDTM Rerun\n\u25cf ADaM Rerun\n\u25cf TLF Rerun\n\u25cf Dry Run Delivery Oversight and Review \u00a9 Copyright 2026 PhaseV Trials Inc. Confi dential, Under CDA only\n5\nInterim / TLR analysis\n\u25cf Interim SDTM Datasets\n\u25cf Interim ADaM Datasets\n\u25cf Interim Tables Unique\n\u25cf Interim Tables Repeat\n\u25cf Interim Listings\n\u25cf Interim Datasets Rerun (Unblinded)\n\u25cf Interim Outputs Rerun (Unblinded)\n\u25cf Interim Delivery Oversight and Review\n\u25cf Interim Datasets Rerun (Unblinded)\n\u25cf Interim Outputs Rerun (Unblinded)\n \nFINAL ANALYSIS\n\u25cf Final: SDTM Rerun\n\u25cf Final: ADaM Rerun\n\u25cf Final: TLF Rerun\n\u25cf Final: Delivery Oversight and Review\n \nProject Management\n\u25cf Project Management Set-Up\n\u25cf Project Management and Meetings\nServices Total Amount: 360,000 $\n\nThis request for proposals is conditional, meaning that the supplier selected in this procedure will be entered into a conditional agreement by the Contracting Authority. The conditional agreement will only come into effect if the Contracting Authority concludes a funding agreement for the project. \n\nFor the avoidance of doubt, in the event that the funding agreement for the Project is not concluded, neither party shall have any liability to the other, except for obligations expressly agreed as pre-contractual.\n\n- The Ordering Party does not allow the possibility of submitting partial offers (1 part of the subject of the order). \n- The Ordering Party does not allow the possibility of submitting variant offers.\n\nORDER COMPLETION DATE: The execution of orders under the contract must take place within max (lead time): to June 2028 The timelines set out above are indicative and may be reasonably adjusted in the event of delays arising from factors beyond the Contractor\u2019s control, including but not limited to site activation timelines, patient recruitment rates, third-party dependencies, or force majeure events.\n","warranty_period":null,"cpv_items":[{"id":8514,"code":"73110000-6","name":"Us\u0142ugi badawcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"id":738583,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"2d3c4483-edad-47b6-b59b-fcda9043cbe0"}],"participation_conditions":[{"id":1851056,"description":"The award of the contract may be applied for by Bidders who:\na. have the authority to carry out a specific activity or activity, if the law imposes an obligation to have such powers;\nb. carry out activities consistent with the description of the subject of the contract;\nc. They have the necessary knowledge and experience and have the technical capacity and persons capable of performing the contract.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"group_uuid":"4f45794d-16ef-4fc4-be85-b3c1890cc2a3"},{"id":1851057,"description":"The award of the contract may be applied for by Bidders who:\nd. are in an economic and financial situation ensuring the performance of the contract;\ne. are not in liquidation or have not been declared bankrupt;\nf. are not in arrears with the payment of public law fees, taxes or social or health insurance\ncontributions \u2013 the Bidder shall submit a statement that it has no arrears due to the above-mentioned receivables (public law fees, taxes, social security or health insurance contributions);\ng. have not been legally convicted of an offence committed in connection with the procurement procedure, bribery offence, a crime against economic turnover or another crime committed in order to obtain financial benefits - concerns a partner in a general partnership, partner or member of the management board of a partner company, a general partner of a limited partnership and a limited joint-stock partnership; a member of the management body of a legal person.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"group_uuid":"0b2199cf-070b-4a37-9593-f7fd386843fb"},{"id":1851058,"description":"h. are not related personally or financially with the Ordering Party (mutual relations between the Ordering Party or persons authorized to incur obligations on behalf of the Ordering Party or persons performing activities related to the selection procedure of the Contractor and the Bidder on behalf of the Ordering Party).\nCapital or personal ties shall be understood as mutual relations between the Ordering Party or persons authorized to incur obligations on behalf of the Ordering Party or persons performing activities on behalf of the Ordering Party related to the preparation and conduct of the procedure for selecting the Contractor and the Contractor, consisting in particular in:\n- participation in the company as a partner in a civil law partnership or partnership, holding at least 10% of shares (unless a lower threshold results from the law), performing the function of a member of a supervisory or management body, proxy, proxy,\n- being married, by kinship or affinity in a direct line, by kinship or affinity in the collateral line up to the second degree, or by virtue of adoption, guardianship or guardianship, or cohabitation with the contractor, its legal representative or members of the management or supervisory bodies of the economic operators applying for the award of the contract,\n- remaining in such a legal or factual relationship with the economic operator that there is reasonable doubt as to their impartiality or independence in connection with the procurement procedure.\ni. are not subject to exclusion pursuant to Article 7(1) of the Act of 13 April 2022 on special solutions for counteracting support for aggression against Ukraine and serving the protection of national security (Journal of Laws, item 835).","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"group_uuid":"2a4b6a08-b890-4d86-aec5-c34c6453eed5"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"group_uuid":"c69015c7-12fc-457f-9c80-e0e0d6a99ada"}],"evaluation_criteria":[{"id":1037483,"price_criterion":true,"description":"Net price (\"C\") \u2013 weight: 100 % (10 points)","created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null,"group_uuid":"0fbd499f-09f6-411a-b3f0-0cfe40eee7d9"}],"is_variant":false,"title":"Us\u0142uga badawcza","order_node":{"id":435902},"created_by":null,"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 19:12:54","modified_by":null}],"created_by":{"id":116497,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"ENLIVEX POLAND SP\u00d3\u0141KA Z OGRANICZON\u0104 ODPOWIEDZIALNO\u015aCI\u0104","identification_number_type":"nip","identification_number":"5253059061","address":{"country":"Polska","voivodeship":"mazowieckie","poviat":"Warszawa","commune":"\u015ar\u00f3dmie\u015bcie","locality":"Warszawa","created_by":{"id":116497,"contact_persons":[]},"created_at":"2026-03-20 19:12:54","modified_at":"2026-03-20 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