{"component": "definition", "props": {"groups": [{"snippet_links": [{"key": "human-clinical-trial", "type": "definition", "offset": [8, 28]}, {"key": "the-product", "type": "definition", "offset": [32, 43]}, {"key": "purpose-of", "type": "clause", "offset": [59, 69]}, {"key": "determination-of", "type": "clause", "offset": [93, 109]}, {"key": "safety-and-efficacy", "type": "clause", "offset": [110, 129]}, {"key": "the-target", "type": "clause", "offset": [133, 143]}, {"key": "patient-population", "type": "clause", "offset": [144, 162]}, {"key": "any-jurisdiction", "type": "definition", "offset": [301, 317]}, {"key": "the-us", "type": "clause", "offset": [326, 333]}], "samples": [{"hash": "gF1XZyS0Nde", "uri": "/contracts/gF1XZyS0Nde#phase-2-study", "label": "License Agreement (Spectrum Pharmaceuticals Inc)", "score": 24.603012085, "published": true}, {"hash": "FU4cl6JIK2", "uri": "/contracts/FU4cl6JIK2#phase-2-study", "label": "License, Development and Commercialization Agreement (Allos Therapeutics Inc)", "score": 23.2313480377, "published": true}, {"hash": "2Lq6aiQLuOa", "uri": "/contracts/2Lq6aiQLuOa#phase-2-study", "label": "License, Development and Commercialization Agreement (Allos Therapeutics Inc)", "score": 22.5879535675, "published": true}], "snippet": "means a human clinical trial of the Product, the principal purpose of which is a preliminary determination of safety and efficacy in the target patient population over a range of doses and dose regimens, as described in 21 C.F.R. \u00a7 312.21(b) (or its successor regulation) or the equivalent thereof in any jurisdiction outside the U.S.", "size": 51, "hash": "2620008c1c2a431a9f49de293d072062", "id": 1}, {"snippet_links": [{"key": "drug-candidate", "type": "definition", "offset": [28, 42]}, {"key": "primary-objective", "type": "clause", "offset": [70, 87]}, {"key": "disease-state", "type": "definition", "offset": [133, 146]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [325, 354]}, {"key": "the-united-states", "type": "definition", "offset": [379, 396]}, {"key": "human-clinical-trial", "type": "definition", "offset": [409, 429]}, {"key": "the-requirements", "type": "clause", "offset": [463, 479]}, {"key": "phase-3-clinical-study", "type": "definition", "offset": [699, 721]}, {"key": "phase-1-2-trial", "type": "definition", "offset": [731, 746]}, {"key": "single-agent", "type": "definition", "offset": [814, 826]}, {"key": "in-combination", "type": "definition", "offset": [830, 844]}], "samples": [{"hash": "dPLAmUnem5k", "uri": "/contracts/dPLAmUnem5k#phase-2-study", "label": "Research, Collaboration & License Agreement (Passage BIO, Inc.)", "score": 35.8665313721, "published": true}, {"hash": "g6gLXuKjQjq", "uri": "/contracts/g6gLXuKjQjq#phase-2-study", "label": "Research, Collaboration & License Agreement (Passage BIO, Inc.)", "score": 31.6146469116, "published": true}, {"hash": "8r2beZGVg9W", "uri": "/contracts/8r2beZGVg9W#phase-2-study", "label": "Research, Collaboration & License Agreement (Passage BIO, Inc.)", "score": 31.0889797211, "published": true}], "snippet": "means a clinical study of a drug candidate in human patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. \u00a7312.21(b), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. \u00a7312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. \u00a7312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Study (e.g., a phase 1/2 trial). The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.", "size": 22, "hash": "6f6733660094fb3daaa5d57cf49b7978", "id": 2}, {"snippet_links": [{"key": "human-clinical-trial", "type": "definition", "offset": [8, 28]}, {"key": "purpose-of", "type": "clause", "offset": [87, 97]}, {"key": "determination-of", "type": "clause", "offset": [109, 125]}, {"key": "safety-and-efficacy", "type": "clause", "offset": [126, 145]}, {"key": "the-target", "type": "clause", "offset": [169, 179]}, {"key": "patient-population", "type": "clause", "offset": [180, 198]}], "samples": [{"hash": "knxU6sgGxaf", "uri": "/contracts/knxU6sgGxaf#phase-2-study", "label": "Exclusive License Agreement (Erasca, Inc.)", "score": 33.2245025635, "published": true}, {"hash": "4gJRxMjC6ka", "uri": "/contracts/4gJRxMjC6ka#phase-2-study", "label": "Exclusive License Agreement (Erasca, Inc.)", "score": 32.4798088074, "published": true}, {"hash": "f5QS7bHrhFY", "uri": "/contracts/f5QS7bHrhFY#phase-2-study", "label": "Exclusive License Agreement (Erasca, Inc.)", "score": 32.4360046387, "published": true}], "snippet": "means a human clinical trial of a compound or product for an Indication, the principal purpose of which is a determination of safety and efficacy for such Indication in the target patient population.", "size": 7, "hash": "0ef0e6b3045aced2fd1c2c747b4a6df9", "id": 3}, {"snippet_links": [{"key": "human-clinical-trial", "type": "definition", "offset": [8, 28]}, {"key": "product-in-class", "type": "definition", "offset": [99, 115]}, {"key": "determine-the", "type": "clause", "offset": [220, 233]}, {"key": "side-effects", "type": "clause", "offset": [252, 264]}, {"key": "associated-with", "type": "definition", "offset": [275, 290]}, {"key": "the-requirements", "type": "clause", "offset": [319, 335]}, {"key": "the-fda", "type": "clause", "offset": [399, 406]}], "samples": [{"hash": "aWqaysHdkOS", "uri": "/contracts/aWqaysHdkOS#phase-2-study", "label": "License Agreement (Inozyme Pharma, Inc.)", "score": 31.4996585846, "published": true}, {"hash": "dRvuDSh0VWf", "uri": "/contracts/dRvuDSh0VWf#phase-2-study", "label": "License Agreement (Inozyme Pharma, Inc.)", "score": 31.3490753174, "published": true}, {"hash": "fAte4iOn0LX", "uri": "/contracts/fAte4iOn0LX#phase-2-study", "label": "License Agreement", "score": 31.3408622742, "published": true}], "snippet": "means a human clinical trial in any country that is conducted to evaluate the effectiveness of the PRODUCT IN CLASS for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug that would satisfy the requirements of 21 CFR 312.21(b), or other comparable regulation imposed by the FDA or its foreign counterpart.", "size": 6, "hash": "c32cbd88c105755da6bc91c5e8dcd77d", "id": 4}, {"snippet_links": [{"key": "clinical-study", "type": "definition", "offset": [8, 22]}, {"key": "investigational-product", "type": "definition", "offset": [29, 52]}, {"key": "primary-objective", "type": "clause", "offset": [74, 91]}, {"key": "disease-state", "type": "definition", "offset": [137, 150]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [360, 389]}, {"key": "the-united-states", "type": "definition", "offset": [414, 431]}, {"key": "human-clinical-trial", "type": "definition", "offset": [444, 464]}, {"key": "the-requirements", "type": "clause", "offset": [498, 514]}, {"key": "phase-3-study", "type": "definition", "offset": [732, 745]}, {"key": "phase-1", "type": "clause", "offset": [755, 762]}], "samples": [{"hash": "jgq6QxC8gvV", "uri": "/contracts/jgq6QxC8gvV#phase-2-study", "label": "License Agreement (Coherus BioSciences, Inc.)", "score": 35.2012329102, "published": true}, {"hash": "48OH0wF4opz", "uri": "/contracts/48OH0wF4opz#phase-2-study", "label": "License Agreement (Surface Oncology, Inc.)", "score": 31.9596176147, "published": true}, {"hash": "jjgXnntRUlU", "uri": "https://investors.surfaceoncology.com/static-files/0d4f7dcd-97cc-409d-bf7a-e1b92580dd73", "label": "investors.surfaceoncology.com", "score": 10.4798088074, "published": false}], "snippet": "means a Clinical Study of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Study (e.g., a Phase 1 Study/ Phase 2 Study).", "size": 6, "hash": "97e3a1a0dec1aa45b9aeecb1abe76b0e", "id": 5}, {"snippet_links": [{"key": "drug-candidate", "type": "definition", "offset": [28, 42]}, {"key": "primary-objective", "type": "clause", "offset": [64, 81]}, {"key": "disease-state", "type": "definition", "offset": [127, 140]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [318, 347]}, {"key": "the-united-states", "type": "definition", "offset": [372, 389]}, {"key": "human-clinical-trial", "type": "definition", "offset": [402, 422]}, {"key": "the-requirements", "type": "clause", "offset": [456, 472]}, {"key": "phase-3-clinical-study", "type": "definition", "offset": [690, 712]}, {"key": "phase-1-2-trial", "type": "definition", "offset": [722, 737]}, {"key": "single-agent", "type": "definition", "offset": [805, 817]}, {"key": "in-combination", "type": "definition", "offset": [821, 835]}], "samples": [{"hash": "lR3Lp5yXGD4", "uri": "/contracts/lR3Lp5yXGD4#phase-2-study", "label": "License Agreement (Amicus Therapeutics, Inc.)", "score": 34.1608505249, "published": true}, {"hash": "43FD10L9T65", "uri": "/contracts/43FD10L9T65#phase-2-study", "label": "Research Collaboration and License Agreement (FS Development Corp.)", "score": 31.9322376251, "published": true}, {"hash": "hFt8Uwd0BgX", "uri": "/contracts/hFt8Uwd0BgX#phase-2-study", "label": "Research, Collaboration & License Agreement (Amicus Therapeutics, Inc.)", "score": 30.1581115723, "published": true}], "snippet": "means a clinical study of a drug candidate in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Study (e.g., a phase 1/2 trial). The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.", "size": 5, "hash": "f1e0db321420f324d7d37995d7ae2c66", "id": 6}, {"snippet_links": [{"key": "human-clinical-trial", "type": "definition", "offset": [8, 28]}, {"key": "licensed-product", "type": "definition", "offset": [34, 50]}, {"key": "the-requirements", "type": "clause", "offset": [85, 101]}], "samples": [{"hash": "7aLaDSAzX3n", "uri": "/contracts/7aLaDSAzX3n#phase-2-study", "label": "Development and Option Agreement (CureVac B.V.)", "score": 31.472278595, "published": true}, {"hash": "cR7WNkYsrf", "uri": "/contracts/cR7WNkYsrf#phase-2-study", "label": "Development and Option Agreement (Arcturus Therapeutics Ltd.)", "score": 29.3641338348, "published": true}], "snippet": "means a human clinical trial of a Licensed Product in any country that would satisfy the requirements of 21 CFR 312.21(b) or corresponding foreign regulations.", "size": 5, "hash": "e6684492053a196ab84fa56ec1fe0103", "id": 7}, {"snippet_links": [{"key": "schedule-a", "type": "clause", "offset": [44, 54]}], "samples": [{"hash": "2mAOBACQKm7", "uri": "/contracts/2mAOBACQKm7#phase-2-study", "label": "Option Agreement (Moderna, Inc.)", "score": 29.8542098999, "published": true}, {"hash": "d5WTWU4mge2", "uri": "/contracts/d5WTWU4mge2#phase-2-study", "label": "Option Agreement (Moderna, Inc.)", "score": 29.7693367004, "published": true}, {"hash": "2lL3mGTdJQs", "uri": "/contracts/2lL3mGTdJQs#phase-2-study", "label": "Option Agreement (Moderna, Inc.)", "score": 29.659822464, "published": true}], "snippet": "has the meaning set forth in Paragraph 1.5 (Schedule A).", "size": 4, "hash": "3b7e2586a3770b631d601dd193bca4ef", "id": 8}, {"snippet_links": [{"key": "investigational-product", "type": "definition", "offset": [29, 52]}, {"key": "primary-objective", "type": "clause", "offset": [74, 91]}, {"key": "disease-state", "type": "definition", "offset": [137, 150]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [328, 357]}, {"key": "the-united-states", "type": "definition", "offset": [382, 399]}, {"key": "human-clinical-trial", "type": "definition", "offset": [412, 432]}, {"key": "the-requirements", "type": "clause", "offset": [466, 482]}, {"key": "phase-3-clinical-study", "type": "definition", "offset": [700, 722]}, {"key": "phase-1-2-trial", "type": "definition", "offset": [732, 747]}, {"key": "single-agent", "type": "definition", "offset": [815, 827]}, {"key": "in-combination", "type": "definition", "offset": [831, 845]}], "samples": [{"hash": "8WEy9hfpyuX", "uri": "/contracts/8WEy9hfpyuX#phase-2-study", "label": "Collaboration Agreement (Coherus BioSciences, Inc.)", "score": 35.2012329102, "published": true}, {"hash": "5FakLyB0nmv", "uri": "/contracts/5FakLyB0nmv#phase-2-study", "label": "Collaboration Agreement (Surface Oncology, Inc.)", "score": 29.2217655182, "published": true}, {"hash": "a77nconioih", "uri": "/contracts/a77nconioih#phase-2-study", "label": "Collaboration Agreement (Surface Oncology, Inc.)", "score": 29.1724853516, "published": true}], "snippet": "means a clinical study of an investigational product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Study (e.g., a phase 1/2 trial). The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and [***]", "size": 4, "hash": "cfa0f8434789c0f061ea945a79776107", "id": 9}, {"snippet_links": [{"key": "clinical-study", "type": "definition", "offset": [8, 22]}, {"key": "investigational-product", "type": "definition", "offset": [29, 52]}, {"key": "primary-objective", "type": "clause", "offset": [74, 91]}, {"key": "disease-state", "type": "definition", "offset": [137, 150]}, {"key": "single-agent", "type": "definition", "offset": [308, 320]}, {"key": "in-combination", "type": "definition", "offset": [324, 338]}, {"key": "first-patient-in", "type": "definition", "offset": [424, 440]}, {"key": "clinical-trial", "type": "definition", "offset": [539, 553]}, {"key": "the-requirements", "type": "clause", "offset": [573, 589]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [665, 694]}, {"key": "the-united-states", "type": "definition", "offset": [719, 736]}], "samples": [{"hash": "5d9vxZc6pU4", "uri": "/contracts/5d9vxZc6pU4#phase-2-study", "label": "Asset Purchase Agreement (MeiraGTx Holdings PLC)", "score": 37.2874755859, "published": true}, {"hash": "aT2yUzRUReG", "uri": "/contracts/aT2yUzRUReG#phase-2-study", "label": "Collaboration, Option and License Agreement (MeiraGTx Holdings PLC)", "score": 36.1950721741, "published": true}, {"hash": "9NgViDloXsb", "uri": "/contracts/9NgViDloXsb#phase-2-study", "label": "Asset Purchase Agreement (MeiraGTx Holdings PLC)", "score": 35.2012329102, "published": true}], "snippet": "means a clinical study of an investigational product in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and shall be deemed commenced when the first patient in such study has received his or her initial dose of a product. A \u201cPhase 2 Study\u201d shall include any clinical trial that would satisfy the requirements of 21 C.F.R. \u00a7 312.21(b), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States.", "size": 4, "hash": "ced1f31df64ce05682546c345572241e", "id": 10}], "next_curs": "CloSVGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjYLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIWcGhhc2UtMi1zdHVkeSMwMDAwMDAwYQyiAQJlbhgAIAA=", "definition": {"snippet": "means a human clinical trial of the Product, the principal purpose of which is a preliminary determination of safety and efficacy in the target patient population over a range of doses and dose regimens, as described in 21 C.F.R. \u00a7 312.21(b) (or its successor regulation) or the equivalent thereof in any jurisdiction outside the U.S.", "title": "Phase 2 Study", "size": 150, "id": "phase-2-study", "examples": ["<strong>Phase 2 Study</strong> in Immunocompromised Persons (HIV-positive adult subjects) (Africa) Study: <strong>Phase 2 study</strong> in immunocompromised persons (HIV-positive adult subjects) (Africa).", "The Agreement concerns the performance of the Study in accordance with Radius Protocol No. BA058-05-007 \u201cA Randomized, Double-Blind, Placebo Controlled, <strong>Phase 2 Study</strong> of BA058 Administered as a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women with Osteoporosis\u201d (the \u201cProtocol\u201d).", "This scope element will integrate the results defined in other NREL <strong>Phase 2 Study</strong> scope elements to the fullest extent practicable.", "For clarity, a Pivotal Study may be a <strong>Phase 2 Study</strong>, a Phase 1/2 Study, or a Phase 3 Study.", "Licensor will have the right, but no obligation, to conduct a <strong>Phase 2 Study</strong> to identify a safe and efficacious dose of the Lead Product for multiple sclerosis (a \u201cPhase 2 MS POC Study\u201d) in accordance with this Section 3.4.", "The JSC shall continue to exist until the first to occur of: (a) Parties mutually agreeing to disband the JSC, (b) Asana providing written notice to Company of its intention to disband and no longer participate in the JSC or (c) the achievement of the <strong>Phase 2 Study</strong> Milestone (and payment of the associated Development Milestone Payment in Section 2.12(a) of the Merger Agreement and issuance of the Milestone Parent Shares).", "For example, if for a Licensed Compound, a Phase 3 Study is started that triggers a Milestone Payment as set forth above without a <strong>Phase 2 Study</strong> supporting such Phase 3 Study being previously started (and consequently the applicable <strong>Phase 2 Study</strong> Milestone Payment under clause 2(b) has not been previously paid to ATI), in addition to the Milestone Payment for the start of the Phase 3 Study, BMS shall also pay to ATI the applicable Milestone Payment for the start of a <strong>Phase 2 Study</strong>.", "Where such a site is closed with the intention of being reopened as soon as is reasonably practicable as a Rallybio <strong>Phase 2 Study</strong> site, the site will be deemed as being continuously maintained for the purposes of classification under the minimum NHS site footprint.", "This <strong>Phase 2 Study</strong> will investigate potential site and facility improvement options both reusing these facilities\u2019 existing sites as well as other potential site or sites in the Village.", "Based upon this investigation the Village has reviewed these findings and determined that this <strong>Phase 2 Study</strong> is needed to explore the options to meet these needs, determine the funding that will be necessary to execute these improvements and layout a plan to schedule and best accomplish the Village\u2019s facility goals."], "related": [["phase-2-trial", "Phase 2 Trial", "Phase 2 Trial"], ["phase-i-study", "Phase I Study", "Phase I Study"], ["phase-3-study", "Phase 3 Study", "Phase 3 Study"], ["phase-iii-study", "Phase III Study", "Phase III Study"], ["phase-ii-study", "Phase II Study", "Phase II Study"]], "related_snippets": [], "updated": "2026-07-04T05:45:54+00:00"}, "json": true, "cursor": ""}}