{"component": "definition", "props": {"groups": [{"size": 2, "snippet": "means the Antigen Express Study Drug and the Merck Study Drug.", "samples": [{"hash": "7FZCnV3WoEo", "uri": "/contracts/7FZCnV3WoEo#study-drugs", "label": "Clinical Trial Agreement (Nugenerex Immuno-Oncology, Inc.)", "score": 31.4449007529, "published": true}, {"hash": "8foOV19PjCa", "uri": "/contracts/8foOV19PjCa#study-drugs", "label": "Clinical Trial Agreement (Generex Biotechnology Corp)", "score": 29.900752909, "published": true}], "snippet_links": [{"key": "study-drug", "type": "definition", "offset": [26, 36]}], "hash": "00ead847eacfa1e01b3472d1c692aa29", "id": 1}, {"size": 1, "snippet": "means all drugs, used in the framework of the Study, including IMP if any. \u201cStudy Steering Committee\u201d: a group of representatives from the EORTC, and representatives from participating groups, with the overall responsibility to supervise the Study and ensure its scientific integrity \u201cStudy Subject\u201d: patients selected in accordance with, and who meet, the eligibility criteria specified in the Protocol. \u201cResults\u201d: all results and/or data obtained within the framework of the Study, and specifically as written out in the final Study report (\u201cFinal Study Report\u201d) 1. DEFINIZIONI I termini di seguito indicati assumono il seguente significato: \u201cContratto\u201d: indica il presente contratto per studio clinico, i suoi documenti allegati e tutti gli emendamenti di seguito firmati dalle Parti. \u201cPropriet\u00e0 intellettuale preesistente\u201d: indica la propriet\u00e0 intellettuale che esisteva gi\u00e0 prima di questo Contratto o \u00e8 stata sviluppata in maniera indipendente dal presente Contratto da una qualsiasi delle Parti. \u201cCRF\u201d o \u201cSchede raccolta dati\u201d: indica le cartelle cliniche elettroniche o cartacee concepite per archiviare tutte le informazioni previste dal Protocollo da segnalare su ogni Soggetto in studio. \u201cDatabase\u201d: indica il mezzo elettronico concepito da EORTC/Gruppo per esigenze legate allo Studio, contenente tutte le informazioni ad esso relative. \u201cHBM\u201d o \u201cMateriale biologico umano\u201d: indica tutti i tessuti e/o fluidi e qualsiasi materiale da essi derivato, modificato e/o non modificato, sotto forma di, a titolo meramente esemplificativo, proteine, DNA, RNA, campioni inclusi in paraffina, campioni congelati, raccolti e/o usati nell\u2019ambito dello Studio, conformemente al Protocollo e al documento di consenso informato firmato dal Soggetto in studio. \u201cIMP\u201d o \u201cMedicinale sperimentale\u201d: indica il farmaco specificamente etichettato e fornito per lo Studio dal Promotore. \u201cComitato etico\u201d: indica il/i comitato/i etico/i istituito/i ai sensi dei requisiti normativi e giuridici locali, allo scopo di revisionare e/o approvare le sperimentazioni cliniche. \u201cGruppo leader\u201d: EORTC, che coordina, unitamente a tutte le parti coinvolte (gruppi partecipanti, promotori di Paesi terzi, l\u2019azienda, ecc.), la realizzazione dello Studio \u201cPromotore legale\u201d: EORTC \u00e8 la persona giuridica che si assume la piena responsabilit\u00e0 per l\u2019avvio e la conduzione di questo Studio conformemente al Protocollo e ai requisiti normativi e giuridici. \u201cRappresentante legale\u201d: indica il soggetto operante presso il Centro partecipante avente diritti legali per la firma del Contratto. \u201cGruppo nazionale di coordinamento\u201d: indica il Gruppo che si propone di agire in qualit\u00e0 di rappresentante nazionale del Promotore legale per gli obiettivi dello Studio nel Paese. Il Gruppo/Centro ha accesso ai centri clinici nel Paese dal quale arruolare i pazienti secondo il Protocollo. \u201cProtocollo\u201d: indica il documento che descrive le procedure dello Studio intitolato \u201cPersonalized Intensity-Modulated Therapy in Post-Pubertal Patients with Newly-Diagnosed Medulloblastoma (PersoMed-I)\u201d \u201cStudio\u201d: indica la ricerca biomedica oggetto del presente Contratto e descritta nel Protocollo EORTC 1634-BTG \u201cFarmaco/i in studio\u201d: indica tutti i farmaci utilizzati nell\u2019ambito dello Studio, incluso l\u2019IMP, se del caso. \u201cComitato direttivo dello Studio\u201d: indica un gruppo di rappresentanti dell\u2019EORTC e di rappresentanti dei gruppi partecipanti, con la responsabilit\u00e0 generale di supervisionare lo Studio e garantirne l\u2019integrit\u00e0 scientifica \u201cSoggetto in studio\u201d: indica i pazienti selezionati in conformit\u00e0 a, e che soddisfano, i criteri di eleggibilit\u00e0 specificati nel Protocollo. \u201cRisultati\u201d: indica tutti i risultati e/o i dati ottenuti nell\u2019ambito dello Studio e, in particolare, come riportati nella Relazione dello studio definitiva (\u201cRelazione dello studio definitiva\u201d)", "samples": [{"hash": "eakqOnYie0u", "uri": "/contracts/eakqOnYie0u#study-drugs", "label": "Clinical Study Agreement", "score": 31.2398504694, "published": true}], "snippet_links": [{"key": "the-framework", "type": "clause", "offset": [25, 38]}, {"key": "the-study", "type": "definition", "offset": [42, 51]}, {"key": "steering-committee", "type": "definition", "offset": [82, 100]}, {"key": "of-representatives", "type": "clause", "offset": [111, 129]}, {"key": "and-representatives", "type": "clause", "offset": [146, 165]}, {"key": "overall-responsibility", "type": "clause", "offset": [202, 224]}, {"key": "scientific-integrity", "type": "definition", "offset": [263, 283]}, {"key": "study-subject", "type": "definition", "offset": [285, 298]}, {"key": "in-accordance-with", "type": "definition", "offset": [319, 337]}, {"key": "eligibility-criteria", "type": "clause", "offset": [357, 377]}, {"key": "the-protocol", "type": "clause", "offset": [391, 403]}, {"key": "as-written", "type": "definition", "offset": [501, 511]}, {"key": "final-study-report", "type": "definition", "offset": [523, 541]}], "hash": "aeed71c84f194c9f60cb57954673c56c", "id": 2}, {"size": 1, "snippet": "means those substances referred to in the Protocol.", "samples": [{"hash": "cmtADdjAbJf", "uri": "/contracts/cmtADdjAbJf#study-drugs", "label": "Agreement for Clinical Services (Cytrx Corp)", "score": 22.1882272416, "published": true}], "snippet_links": [{"key": "the-protocol", "type": "clause", "offset": [38, 50]}], "hash": "d9bc118ab362e90ba3d2cea75581ab63", "id": 3}, {"size": 1, "snippet": "RP103: Cysteamine Bitartrate Delayed-release Capsules (75 mg and 25 mg of cysteamine free-base per capsule).", "samples": [{"hash": "i8u8hg85G30", "uri": "/contracts/i8u8hg85G30#study-drugs", "label": "Investigator Agreement", "score": 27.2743630963, "published": true}], "snippet_links": [], "hash": "3c1a0f3bbebebca2e43f62994760df45", "id": 4}, {"size": 1, "snippet": "means those substances referred to in the Protocol. 2. SERVICES 2.1 CRO shall provide the Services in accordance with the terms hereof. Any changes made to the Protocol must be approved in advance in writing by SPONSOR and must receive the necessary Institutional Review Board (\u201cIRB\u201d) approval and, if required by 21 C.F.R. \u00a7 312.30, be submitted to the FDA prior to implementation. In the event of revision of the Protocol or an Exhibit hereto, the most recent version or revision thereof shall govern. CRO shall comply with the Protocol, all applicable federal, state and local laws, rules and regulations including, without limitation, the rules and regulations promulgated by FDA, with respect to the Services performed by CRO hereunder, including, but not limited to, the requirements of 21 C.F.R. Part 312, Good Clinical Practices, including but not limited to the Drug and Cosmetic Act, 1940 and the regulations promulgated pursuant thereto, and with the standard of care customary in the contract research organization industry. In the event of any actual or perceived noncompliance with the Protocol, or with applicable federal, state, or local laws, rules, or regulations that may affect the integrity of Study data, CRO shall notify SPONSOR immediately.\n2.2.1 CRO shall use its best endeavors to deliver the maximum enrollment to SPONSOR of no less than 140 enrolled patients.\n2.2.2 CRO shall use its best endeavors to deliver to SPONSOR no less than TWELVE sites within the United States for this study and will work with the THREE sites in Mexico City, Mexico that have been identified by the SPONSOR for this study. 2.3 CRO shall also provide additional Services specified in any future additions or modifications, which may be agreed to among all of the parties and shall be incorporated in writing as amendments of the relevant Exhibit hereto. If SPONSOR wishes to change the scope of the Services or wishes to obtain additional Services not initially covered by this Agreement and/or not listed in an Exhibit hereto, SPONSOR shall so advise CRO and submit requirements and specifications to CRO. After receipt of the requirements and specifications, CRO shall provide SPONSOR with a reasonable cost estimate for performing the modified or additional Services. No such cost estimate shall be the basis for a change in the fees payable to CRO unless and until it has been agreed to and approved in writing by SPONSOR. In the event there is no agreement among the parties with respect to such additional costs, the parties agree to resolve any differences as provided in Section 4.1 below. Any such modified or additional Services provided by the CRO thereby shall be governed by the terms and conditions of this Agreement and by such supplementary written amendments of this Agreement or Exhibits to this Agreement as may be executed among the parties from time to time. In the event of a conflict between the terms of this Agreement and an Exhibit, the terms of this Agreement shall govern.", "samples": [{"hash": "k1Odx44SGrm", "uri": "/contracts/k1Odx44SGrm#study-drugs", "label": "Clinical Services Agreement", "score": 30.340862423, "published": true}], "snippet_links": [{"key": "the-protocol", "type": "clause", "offset": [38, 50]}, {"key": "provide-the", "type": "clause", "offset": [78, 89]}, {"key": "in-accordance-with", "type": "definition", "offset": [99, 117]}, {"key": "in-advance", "type": "clause", "offset": [186, 196]}, {"key": "in-writing", "type": "definition", "offset": [197, 207]}, {"key": "by-sponsor", "type": "clause", "offset": [208, 218]}, {"key": "institutional-review-board", "type": "clause", "offset": [250, 276]}, {"key": "required-by", "type": "definition", "offset": [302, 313]}, {"key": "the-fda", "type": "clause", "offset": [350, 357]}, {"key": "prior-to", "type": "clause", "offset": [358, 366]}, {"key": "revision-of", "type": "clause", "offset": [399, 410]}, {"key": "most-recent", "type": "definition", "offset": [450, 461]}, {"key": "comply-with-the", "type": "clause", "offset": [514, 529]}, {"key": "state-and-local-laws", "type": "clause", "offset": [564, 584]}, {"key": "rules-and-regulations", "type": "definition", "offset": [586, 607]}, {"key": "without-limitation", "type": "clause", "offset": [619, 637]}, {"key": "the-rules", "type": "clause", "offset": [639, 648]}, {"key": "by-cro", "type": "clause", "offset": [724, 730]}, {"key": "not-limited", "type": "clause", "offset": [757, 768]}, {"key": "the-requirements", "type": "clause", "offset": [773, 789]}, {"key": "good-clinical-practices", "type": "definition", "offset": [813, 836]}, {"key": "the-regulations", "type": "clause", "offset": [903, 918]}, {"key": "standard-of-care", "type": "definition", "offset": [962, 978]}, {"key": "contract-research-organization", "type": "definition", "offset": [996, 1026]}, {"key": "integrity-of", "type": "clause", "offset": [1202, 1214]}, {"key": "study-data", "type": "clause", "offset": [1215, 1225]}, {"key": "best-endeavors", "type": "definition", "offset": [1289, 1303]}, {"key": "maximum-enrollment", "type": "clause", "offset": [1319, 1337]}, {"key": "deliver-to", "type": "definition", "offset": [1430, 1440]}, {"key": "within-the-united-states", "type": "clause", "offset": [1475, 1499]}, {"key": "will-work", "type": "clause", "offset": [1519, 1528]}, {"key": "the-sponsor", "type": "clause", "offset": [1602, 1613]}, {"key": "additions-or-modifications", "type": "clause", "offset": [1701, 1727]}, {"key": "agreed-to", "type": "definition", "offset": [1742, 1751]}, {"key": "of-the-parties", "type": "clause", "offset": [1762, 1776]}, {"key": "the-relevant", "type": "clause", "offset": [1831, 1843]}, {"key": "the-scope-of-the-services", "type": "clause", "offset": [1888, 1913]}, {"key": "covered-by-this-agreement", "type": "clause", "offset": [1968, 1993]}, {"key": "requirements-and-specifications", "type": "clause", "offset": [2073, 2104]}, {"key": "after-receipt-of", "type": "clause", "offset": [2113, 2129]}, {"key": "cost-estimate", "type": "clause", "offset": [2211, 2224]}, {"key": "the-basis", "type": "clause", "offset": [2308, 2317]}, {"key": "a-change-in", "type": "definition", "offset": [2322, 2333]}, {"key": "payable-to", "type": "definition", "offset": [2343, 2353]}, {"key": "been-agreed", "type": "clause", "offset": [2382, 2393]}, {"key": "no-agreement", "type": "clause", "offset": [2455, 2467]}, {"key": "additional-costs", "type": "clause", "offset": [2507, 2523]}, {"key": "agree-to", "type": "clause", "offset": [2537, 2545]}, {"key": "section-41", "type": "clause", "offset": [2585, 2596]}, {"key": "services-provided-by", "type": "clause", "offset": [2636, 2656]}, {"key": "terms-and-conditions-of-this-agreement", "type": "clause", "offset": [2698, 2736]}, {"key": "agreement-or", "type": "definition", "offset": [2790, 2802]}, {"key": "exhibits-to-this-agreement", "type": "clause", "offset": [2803, 2829]}, {"key": "from-time-to-time", "type": "clause", "offset": [2867, 2884]}, {"key": "in-the-event-of-a", "type": "clause", "offset": [2886, 2903]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [2925, 2948]}], "hash": "9eb56bfeffaba1e58315463bf24cb5e2", "id": 5}, {"size": 1, "snippet": "means Trastuzumab and Pertuzumab supplied for the Study by Genentech.", "samples": [{"hash": "d5qIAUNHNFe", "uri": "/contracts/d5qIAUNHNFe#study-drugs", "label": "Clinical Trial Agreement (Celcuity LLC)", "score": 28.6413415469, "published": true}], "snippet_links": [{"key": "the-study", "type": "definition", "offset": [46, 55]}, {"key": "by-genentech", "type": "clause", "offset": [56, 68]}], "hash": "30d2a76f72e772b9bc2738cc0bcd6192", "id": 6}, {"size": 1, "snippet": "means the investigational medicinal products and includes the medicinal products under investigation, xx for this study Suspected Unexpected Serious Adverse Reaction \u201cSUSAR\u201d means a Serious Adverse Reaction the nature or severity of which is not consistent with the reference safety information;", "samples": [{"hash": "eokHQT7FMXW", "uri": "/contracts/eokHQT7FMXW#study-drugs", "label": "Research Agreement", "score": 33.1057076215, "published": true}], "snippet_links": [{"key": "investigational-medicinal-products", "type": "clause", "offset": [10, 44]}, {"key": "under-investigation", "type": "definition", "offset": [81, 100]}, {"key": "suspected-unexpected-serious-adverse-reaction", "type": "definition", "offset": [120, 165]}, {"key": "the-nature", "type": "clause", "offset": [207, 217]}, {"key": "consistent-with-the", "type": "clause", "offset": [246, 265]}, {"key": "reference-safety-information", "type": "definition", "offset": [266, 294]}], "hash": "7d48ccca44990ab3a254896b28ca5bfe", "id": 7}, {"size": 1, "snippet": "means, with respect to each Clinical Study, the active drug(s) and placebo that is the subject of such Clinical Study, as more particularly described in the Task Order applicable thereto.", "samples": [{"hash": "9eFAs0ychdi", "uri": "/contracts/9eFAs0ychdi#study-drugs", "label": "Master Services Agreement (Amarin Corp Plc\\uk)", "score": 21.0, "published": true}], "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "clinical-study", "type": "clause", "offset": [28, 42]}, {"key": "subject-of", "type": "clause", "offset": [87, 97]}, {"key": "task-order", "type": "clause", "offset": [157, 167]}], "hash": "01c930f66be585537a94cf8fd8d8027a", "id": 8}, {"size": 1, "snippet": "The investigational study drug Psilocybin \u201cCOMP 360\u201d, formulated as described in the Protocol and manufactured and supplied by the Sponsor or by third party engaged by Sponsor. Study Drug is not psilocybin purchashed and/or manufactured from different sources other than Sponsor and used in investigations preformed by the Investigator outside and different from the Study.", "samples": [{"hash": "ax89kKOcKeZ", "uri": "/contracts/ax89kKOcKeZ#study-drugs", "label": "Clinical Study Agreement", "score": 31.6328739036, "published": true}], "snippet_links": [{"key": "study-drug", "type": "definition", "offset": [20, 30]}, {"key": "the-protocol", "type": "clause", "offset": [81, 93]}, {"key": "the-sponsor", "type": "clause", "offset": [127, 138]}, {"key": "third-party", "type": "clause", "offset": [145, 156]}, {"key": "by-sponsor", "type": "clause", "offset": [165, 175]}, {"key": "the-investigator", "type": "clause", "offset": [319, 335]}, {"key": "the-study", "type": "definition", "offset": [363, 372]}], "hash": "8ab852dcfc1a3d320c4d48da0222ffa9", "id": 9}, {"size": 1, "snippet": "all drugs, used in the framework of the Study including IMP(s) (investigational medicinal product(s)) and AMP(s) (auxiliary medicinal product(s)), as further detailed in the Protocol.", "samples": [{"hash": "lSgzQPje0Yk", "uri": "/contracts/lSgzQPje0Yk#study-drugs", "label": "Clinical Study Agreement", "score": 34.5336797331, "published": true}], "snippet_links": [{"key": "the-framework", "type": "clause", "offset": [19, 32]}, {"key": "the-study", "type": "definition", "offset": [36, 45]}, {"key": "the-protocol", "type": "clause", "offset": [170, 182]}], "hash": "00fd408aed32beb0531ba9969b006792", "id": 10}], "next_curs": "ClgSUmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjQLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIUc3R1ZHktZHJ1Z3MjMDAwMDAwMGEMogECZW4YACAA", "definition": {"size": 13, "title": "Study Drugs", "snippet": "means the Antigen Express Study Drug and the Merck Study Drug.", "id": "study-drugs", "examples": ["Neither Institution nor Investigator will seek reimbursement from any government healthcare program or third party payor for amounts paid by or on behalf of Sponsor, or for any materials that were provided by or on behalf of Sponsor at no cost to Institution or Investigator (such as the Study Drug(s)).", "Sponsor or Sponsor representative shall provide all <strong>Study Drugs</strong> and certain reagents or other materials as provided for in the Protocol (collectively, \u201cMaterials\u201d) to the Institution at no charge.", "Novartis shall Manufacture or have Manufactured the Novartis <strong>Study Drugs</strong> in such quantities as reasonably needed, and at the points in time as needed to meet the timelines in the applicable Protocol in accordance with the Development Plan, for the Combined Therapy Clinical Trials, and shall supply such Novartis <strong>Study Drugs</strong> to Olema or its designee for use solely in the Combined Therapy Clinical Trials.", "Novartis will, [***], deliver the Novartis <strong>Study Drugs</strong> in accordance with the terms of the Supply Agreement to the Olema-designated location in the United States for use in the applicable Combined Therapy Clinical Trial, and otherwise subject to and in accordance with the additional delivery information, and qualitative and quantitative criteria specified in the Quality Documentation.", "Novartis represents and warrants that the Novartis <strong>Study Drugs</strong> manufactured and supplied hereunder shall, at the time of Delivery: (a) comply with the specifications for such drug product (as set forth in the regulatory approvals for such product; (b) shall have been manufactured in accordance with all Applicable Laws; and (c) shall not be adulterated or misbranded as such terms are defined in accordance with Applicable Laws.", "Novartis will be responsible for obtaining all required documents and approvals in order for Novartis <strong>Study Drugs</strong> to clear customs in applicable countries necessary for Delivery of Novartis <strong>Study Drugs</strong> to Olema hereunder.", "If Novartis <strong>Study Drugs</strong> supplied by Novartis is, at the time of delivery to Olema or its designee, non-conforming with the warranty in Section 9.12, or after delivery becomes non-conforming due to fault of Novartis, then [***].", "Subject to Section 4.6, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to supply or use of the Novartis <strong>Study Drugs</strong> in connection with this Agreement.", "Olema shall use the quantities of Novartis <strong>Study Drugs</strong> supplied to it under this Agreement solely as reasonably needed for, and in accordance with, this Agreement and the applicable Protocol, and for no other purpose, including as a reagent or tool to facilitate its internal research efforts, for any commercial (i.e., non-clinical) purpose, or for other clinical or non-clinical research unrelated to the Combined Therapy Clinical Trials.", "Each Party will designate an individual (the \u201cDesignated Supply Contact\u201d) that a Party may contact to assist with coordinating supplies and facilitating the resolution of any issues or concerns arising in connection with the supply of the Novartis <strong>Study Drugs</strong> for use in the Combined Therapy Clinical Trials, except as required by Applicable Law."], "related": [["study", "Study", "Study"], ["study-data", "Study Data", "Study Data"], ["study-materials", "Study Materials", "Study Materials"], ["clinical-laboratory", "Clinical laboratory", "Clinical laboratory"], ["vaccine", "Vaccine", "Vaccine"]], "related_snippets": [], "updated": "2025-07-06T21:58:36+00:00"}, "json": true, "cursor": ""}}