{"component": "definition", "props": {"groups": [{"samples": [{"hash": "kdfUt8L3aWT", "uri": "/contracts/kdfUt8L3aWT#test-article", "label": "Cooperative Research and Development Agreement", "score": 31.6812076569, "published": true}, {"hash": "l3h9e14RGGD", "uri": "/contracts/l3h9e14RGGD#test-article", "label": "Cooperative Research and Development Agreement", "score": 29.8362159729, "published": true}, {"hash": "8YP4jSO9hYH", "uri": "/contracts/8YP4jSO9hYH#test-article", "label": "Cooperative Research and Development Agreement (Bavarian Nordic a/S / ADR)", "score": 27.0068454742, "published": true}], "snippet": "means, in accordance with 21 C.F.R. \u00a7 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [69, 87]}, {"key": "food-additive", "type": "definition", "offset": [106, 119]}, {"key": "color-additive", "type": "definition", "offset": [121, 135]}, {"key": "electronic-product", "type": "clause", "offset": [137, 155]}, {"key": "subject-to-regulation", "type": "definition", "offset": [178, 199]}, {"key": "research-plan", "type": "clause", "offset": [355, 368]}, {"key": "appendix-b", "type": "definition", "offset": [373, 383]}, {"key": "scope-of-the", "type": "clause", "offset": [409, 421]}, {"key": "investigational-agent", "type": "definition", "offset": [481, 502]}, {"key": "study-material", "type": "definition", "offset": [504, 518]}, {"key": "study-product", "type": "definition", "offset": [523, 536]}], "size": 29, "hash": "cecac1e9a19eb394c0fd2bea7f4d9690", "id": 1}, {"samples": [{"hash": "3flFgYp4LNX", "uri": "https://tradebarriers.org/library/regulations/Mauritius/CLINICAL%20TRIALS%20ACT%202011.pdf", "label": "tradebarriers.org", "score": 14.4199180603, "published": false}, {"hash": "195ciD3Ecrt", "uri": "https://www.cidp-cro.com/wp-content/uploads/2021/12/clinical-trials-act-201120171002021049_1_0-1.pdf", "label": "www.cidp-cro.com", "score": 14.2690601349, "published": false}, {"hash": "jWwSKdJlxCx", "uri": "https://mauritiusassembly.govmu.org/Documents/Acts/2011/act0811.pdf", "label": "mauritiusassembly.govmu.org", "score": 8.597536087, "published": false}], "snippet": "means any drug (including a biological product for human use), human food additive, colour additive, or other substance intended for administration to a human being;", "snippet_links": [{"key": "biological-product", "type": "definition", "offset": [28, 46]}, {"key": "human-use", "type": "clause", "offset": [51, 60]}, {"key": "food-additive", "type": "definition", "offset": [69, 82]}, {"key": "human-being", "type": "definition", "offset": [153, 164]}], "size": 9, "hash": "e7872095da8153857faa446e046cf117", "id": 2}, {"samples": [{"hash": "iBZ7zIHobjx", "uri": "/contracts/iBZ7zIHobjx#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 26.6043796539, "published": true}, {"hash": "1JmPAe45pKp", "uri": "/contracts/1JmPAe45pKp#test-article", "label": "Cooperative Research and Development Agreement (Genesis Biopharma, Inc)", "score": 22.9082813263, "published": true}, {"hash": "g7s66DtSKks", "uri": "/contracts/g7s66DtSKks#test-article", "label": "Cooperative Research and Development Agreement (Genesis Biopharma, Inc)", "score": 22.7796039581, "published": true}], "snippet": "means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. PHS ICT-CRADA Case Ref. No. _______ MODEL ADOPTED June 18, 2009", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [68, 86]}, {"key": "food-additive", "type": "definition", "offset": [105, 118]}, {"key": "color-additive", "type": "definition", "offset": [120, 134]}, {"key": "electronic-product", "type": "clause", "offset": [136, 154]}, {"key": "subject-to-regulation", "type": "definition", "offset": [177, 198]}, {"key": "research-plan", "type": "clause", "offset": [354, 367]}, {"key": "appendix-b", "type": "definition", "offset": [372, 382]}, {"key": "scope-of-the", "type": "clause", "offset": [408, 420]}, {"key": "investigational-agent", "type": "definition", "offset": [480, 501]}, {"key": "study-material", "type": "definition", "offset": [503, 517]}, {"key": "study-product", "type": "definition", "offset": [522, 535]}], "size": 7, "hash": "0443022d67030383c47ae310bd3bf9d7", "id": 3}, {"samples": [{"hash": "56JW7erXK2r", "uri": "https://www.trinityhealthofne.org/sites/default/files/hg_features/mercury_standard_layout/bddac2c2ca5e7d4622b99dffbe07821e.pdf", "label": "www.trinityhealthofne.org", "score": 13.3247499466, "published": false}, {"hash": "206hJ3dAvQd", "uri": "https://www.trinityhealthofne.org/assets/documents/clinical-trials-and-research/institutional-review-board/policy-and-procedures-irb-01-2024.pdf", "label": "www.trinityhealthofne.org", "score": 12.0800819397, "published": false}, {"hash": "afyAgcEOaSb", "uri": "https://www.trinityhealthofne.org/assets/documents/clinical-trials-and-research/institutional-review-board/policy-and-procedures-irb-2022.pdf", "label": "www.trinityhealthofne.org", "score": 11.0260095596, "published": false}], "snippet": "means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulation.", "snippet_links": [{"key": "human-use", "type": "clause", "offset": [19, 28]}, {"key": "biological-product", "type": "definition", "offset": [30, 48]}, {"key": "food-additive", "type": "definition", "offset": [100, 113]}, {"key": "color-additive", "type": "definition", "offset": [115, 129]}, {"key": "electronic-product", "type": "clause", "offset": [131, 149]}, {"key": "subject-to", "type": "clause", "offset": [172, 182]}, {"key": "fda-regulation", "type": "clause", "offset": [183, 197]}], "size": 5, "hash": "109ae3bdc459888e7b46a2dd2170a291", "id": 4}, {"samples": [{"hash": "c4dkIZkOW8O", "uri": "/contracts/c4dkIZkOW8O#test-article", "label": "Cooperative Research and Development Agreement (Globeimmune Inc)", "score": 25.3832988739, "published": true}, {"hash": "i45dSC1KRbI", "uri": "/contracts/i45dSC1KRbI#test-article", "label": "Cooperative Research and Development Agreement (Globeimmune Inc)", "score": 25.2053394318, "published": true}], "snippet": "means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic, as which for the purposes of the clinical studies to be conducted under this CRADA shall be the Tarmogens identified in the Research Plan and Appendix B,that is used within the scope-of-the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [68, 86]}, {"key": "food-additive", "type": "definition", "offset": [105, 118]}, {"key": "color-additive", "type": "definition", "offset": [120, 134]}, {"key": "electronic-product", "type": "clause", "offset": [136, 154]}, {"key": "subject-to-regulation", "type": "definition", "offset": [177, 198]}, {"key": "purposes-of-the", "type": "clause", "offset": [351, 366]}, {"key": "clinical-studies", "type": "definition", "offset": [367, 383]}, {"key": "research-plan", "type": "clause", "offset": [458, 471]}, {"key": "appendix-b", "type": "definition", "offset": [476, 486]}, {"key": "within-the-scope", "type": "clause", "offset": [500, 516]}, {"key": "investigational-agent", "type": "definition", "offset": [583, 604]}, {"key": "study-material", "type": "definition", "offset": [606, 620]}, {"key": "study-product", "type": "definition", "offset": [625, 638]}, {"key": "certain-confidential-information", "type": "clause", "offset": [646, 678]}, {"key": "contained-in", "type": "definition", "offset": [679, 691]}, {"key": "the-securities-and-exchange-commission", "type": "clause", "offset": [741, 779]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [780, 796]}, {"key": "securities-act-of-1933", "type": "definition", "offset": [808, 830]}, {"key": "as-amended", "type": "definition", "offset": [832, 842]}], "size": 4, "hash": "2e538d74ee67b2ba234ff11b93430d3e", "id": 5}, {"samples": [{"hash": "aslzHuR9mSZ", "uri": "/contracts/aslzHuR9mSZ#test-article", "label": "Cooperative Research and Development Agreement", "score": 31.3408622742, "published": true}, {"hash": "h9mKkVMFLjU", "uri": "/contracts/h9mKkVMFLjU#test-article", "label": "Cooperative Research and Development Agreement (Globeimmune Inc)", "score": 23.4996585846, "published": true}], "snippet": "means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. PHS ICT-CRADA Case Ref. No. MODEL ADOPTED 2005 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [68, 86]}, {"key": "food-additive", "type": "definition", "offset": [105, 118]}, {"key": "color-additive", "type": "definition", "offset": [120, 134]}, {"key": "electronic-product", "type": "clause", "offset": [136, 154]}, {"key": "subject-to-regulation", "type": "definition", "offset": [177, 198]}, {"key": "research-plan", "type": "clause", "offset": [354, 367]}, {"key": "appendix-b", "type": "definition", "offset": [372, 382]}, {"key": "scope-of-the", "type": "clause", "offset": [408, 420]}, {"key": "investigational-agent", "type": "definition", "offset": [480, 501]}, {"key": "study-material", "type": "definition", "offset": [503, 517]}, {"key": "study-product", "type": "definition", "offset": [522, 535]}, {"key": "certain-confidential-information", "type": "clause", "offset": [590, 622]}, {"key": "contained-in", "type": "definition", "offset": [623, 635]}, {"key": "the-securities-and-exchange-commission", "type": "clause", "offset": [685, 723]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [724, 740]}, {"key": "securities-exchange-act-of-1934", "type": "definition", "offset": [754, 785]}, {"key": "as-amended", "type": "definition", "offset": [787, 797]}], "size": 4, "hash": "f31b2ef3709eabb424dc31ac9e8371c2", "id": 6}, {"samples": [{"hash": "3m4XEd67qx4", "uri": "/contracts/3m4XEd67qx4#test-article", "label": "Clinical Trial Agreement (Amplitude Healthcare Acquisition Corp)", "score": 32.603012085, "published": true}], "snippet": "means, in accordance with 21 C.F.R. Part 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, material or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7\u00a7 301, et seq., Pub. L.No.75-717, 52 Stat. 1040 (1938), as amended. In this Agreement, JSP-191 and CD34+CD90+ HSC are referred to as the \u201cTest Article\u201d.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [72, 90]}, {"key": "food-additive", "type": "definition", "offset": [109, 122]}, {"key": "color-additive", "type": "definition", "offset": [124, 138]}, {"key": "electronic-product", "type": "clause", "offset": [140, 158]}, {"key": "subject-to-regulation", "type": "definition", "offset": [190, 211]}, {"key": "as-amended", "type": "definition", "offset": [327, 337]}, {"key": "in-this-agreement", "type": "definition", "offset": [339, 356]}], "size": 4, "hash": "6552b6777a2a65df8c6d2b6d6b8f35e2", "id": 7}, {"samples": [{"hash": "iBZ7zIHobjx", "uri": "/contracts/iBZ7zIHobjx#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 26.6043796539, "published": true}, {"hash": "do93g6OpnFK", "uri": "/contracts/do93g6OpnFK#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 25.377822876, "published": true}, {"hash": "doHeAdFfhfn", "uri": "/contracts/doHeAdFfhfn#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 25.2546195984, "published": true}], "snippet": "in Article 2 to read as follows:", "snippet_links": [{"key": "article-2", "type": "definition", "offset": [3, 12]}], "size": 3, "hash": "e4db8f03ecd4fb36dd5d95513dbccaa7", "id": 8}, {"samples": [{"hash": "iBZ7zIHobjx", "uri": "/contracts/iBZ7zIHobjx#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 26.6043796539, "published": true}, {"hash": "do93g6OpnFK", "uri": "/contracts/do93g6OpnFK#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 25.377822876, "published": true}, {"hash": "doHeAdFfhfn", "uri": "/contracts/doHeAdFfhfn#test-article", "label": "Cooperative Research and Development Agreement (Kite Pharma, Inc.)", "score": 25.2546195984, "published": true}], "snippet": "means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. For the purposes of this CRADA, \u201cTest Article\u201d shall be provided solely by the Party which is the IND holder for a clinical study.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [7, 25]}, {"key": "biological-product", "type": "definition", "offset": [68, 86]}, {"key": "food-additive", "type": "definition", "offset": [105, 118]}, {"key": "color-additive", "type": "definition", "offset": [120, 134]}, {"key": "electronic-product", "type": "clause", "offset": [136, 154]}, {"key": "subject-to-regulation", "type": "definition", "offset": [177, 198]}, {"key": "research-plan", "type": "clause", "offset": [354, 367]}, {"key": "appendix-b", "type": "definition", "offset": [372, 382]}, {"key": "scope-of-the", "type": "clause", "offset": [408, 420]}, {"key": "investigational-agent", "type": "definition", "offset": [480, 501]}, {"key": "study-material", "type": "definition", "offset": [503, 517]}, {"key": "study-product", "type": "definition", "offset": [522, 535]}, {"key": "for-the-purposes-of", "type": "clause", "offset": [537, 556]}, {"key": "provided-solely", "type": "definition", "offset": [593, 608]}, {"key": "the-party", "type": "clause", "offset": [612, 621]}, {"key": "clinical-study", "type": "definition", "offset": [652, 666]}], "size": 3, "hash": "08dfe0b5b265ccd70e2d533bdbd1db19", "id": 9}, {"samples": [{"hash": "wpZpMtb1L", "uri": "/contracts/wpZpMtb1L#test-article", "label": "Cooperative Research and Development Agreement (Crada)", "score": 29.0187644958, "published": true}, {"hash": "3q4olsroZlV", "uri": "/contracts/3q4olsroZlV#test-article", "label": "Cooperative Research and Development Agreement (Crada)", "score": 24.1704311371, "published": true}], "snippet": "means the drug [name or describe drug] that is the subject of the Protocol (21 U.S.C. \u00a7 301 et seq.).", "snippet_links": [{"key": "the-protocol", "type": "clause", "offset": [62, 74]}], "size": 3, "hash": "1d5588b7206e5c8781993260b01ad342", "id": 10}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIVdGVzdC1hcnRpY2xlIzAwMDAwMDBhDKIBAmVuGAAgAA==", "definition": {"snippet": "means, in accordance with 21 C.F.R. \u00a7 50.3(j), any drug (including a biological product), medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product.", "size": 85, "title": "Test Article", "id": "test-article", "examples": ["Furthermore, IC agrees that no analysis or modification of the <strong>Test Article</strong> will be performed without Collaborator\u2019s prior written consent.", "Collaborator will ship the <strong>Test Article</strong> and, if required, Placebo to IC in containers marked in accordance with 21 C.F.R. \u00a7 312.6. IC agrees that the Clinical Investigators will keep appropriate records and take reasonable steps to ensure that the <strong>Test Article</strong> is used in accordance with the Protocol(s) and applicable FDA regulations.", "At the completion of the Research Plan, any unused quantity of <strong>Test Article</strong> will be returned to Collaborator or disposed as directed by Collaborator.", "In addition, IC agrees that the <strong>Test Article</strong> (and all Confidential Information supplied by Collaborator relating to the <strong>Test Article</strong>) will be used solely for the conduct of the CRADA research and development activities.", "If Collaborator suspends development of the <strong>Test Article</strong> without the transfer of its active development efforts, assets, and obligations to a third party within ninety (90) days of discontinuation, Collaborator agrees that IC may continue developing the <strong>Test Article</strong>.", "Collaborator will provide a Certificate of Analysis to IC for each lot of the <strong>Test Article</strong> provided.", "If Collaborator terminates this Agreement before the completion of all approved or active Protocol(s), then Collaborator will supply enough <strong>Test Article</strong> (and Placebo, if applicable) to complete these Protocol(s) unless termination is for safety concerns.", "Collaborator agrees to provide IC without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade <strong>Test Article</strong> (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA."], "related": [["covered-article", "Covered article", "Covered article"], ["model-articles", "Model Articles", "Model Articles"], ["biomarker-testing", "Biomarker testing", "Biomarker testing"], ["pyrolysis", "Pyrolysis", "Pyrolysis"], ["harvested-material", "Harvested Material", "Harvested Material"]], "related_snippets": [], "updated": "2025-07-12T05:45:48+00:00"}, "json": true, "cursor": ""}}