{"component": "clause", "props": {"groups": [{"snippet": "Licensee shall have the sole right and responsibility for, and control over, all development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products and Licensed Services in the Field.", "samples": [{"hash": "5Clh2FgMM9G", "uri": "/contracts/5Clh2FgMM9G#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement", "score": 31.3408622742, "published": true}, {"hash": "1IWVjLo3dsr", "uri": "/contracts/1IWVjLo3dsr#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement", "score": 31.3408622742, "published": true}, {"hash": "2h5wDnJHa1T", "uri": "/contracts/2h5wDnJHa1T#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement (Homology Medicines, Inc.)", "score": 29.2108154297, "published": true}], "size": 18, "snippet_links": [{"key": "licensee-shall", "type": "clause", "offset": [0, 14]}, {"key": "responsibility-for", "type": "clause", "offset": [39, 57]}, {"key": "commercialization-activities", "type": "definition", "offset": [112, 140]}, {"key": "regulatory-activities", "type": "clause", "offset": [156, 177]}, {"key": "with-respect-to", "type": "clause", "offset": [179, 194]}, {"key": "licensed-products", "type": "definition", "offset": [195, 212]}, {"key": "in-the-field", "type": "clause", "offset": [235, 247]}], "hash": "cc04f83a0be6f8b3ff73b4cf7cea0895", "id": 1}, {"snippet": "Dicerna shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Fields.", "samples": [{"hash": "7ua4c1rZI3Q", "uri": "/contracts/7ua4c1rZI3Q#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement (Dicerna Pharmaceuticals Inc)", "score": 25.0739212036, "published": true}, {"hash": "alJ3PLrAV6b", "uri": "/contracts/alJ3PLrAV6b#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement (Dicerna Pharmaceuticals Inc)", "score": 24.9972629547, "published": true}], "size": 2, "snippet_links": [{"key": "responsibility-for", "type": "clause", "offset": [38, 56]}, {"key": "commercialization-activities", "type": "definition", "offset": [121, 149]}, {"key": "regulatory-activities", "type": "clause", "offset": [165, 186]}, {"key": "with-respect-to", "type": "clause", "offset": [188, 203]}, {"key": "licensed-products", "type": "definition", "offset": [204, 221]}], "hash": "2fffdcefc3c13fce1259f68c475e951a", "id": 2}, {"snippet": "Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for the development, manufacturing, registration and sale of the Licensed Product(s). Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for all marketing and promotional activities related to Licensed Product(s) in the Territory and shall decide on the strategy regarding such activities. Otonomy shall use Commercially Reasonable Efforts to develop, obtain Approvals for, promote and sell Licensed Product(s) being granted Approval in the Territory, it being understood that the efforts of Otonomy\u2019s Affiliates and Sublicensees shall count towards Otonomy\u2019s own Commercially Reasonable Efforts.", "samples": [{"hash": "dR3vQTZ1OjY", "uri": "/contracts/dR3vQTZ1OjY#development-and-commercialization-responsibilities", "label": "License and Commercialization Agreement (Otonomy, Inc.)", "score": 25.5229301453, "published": true}, {"hash": "i7tEJHG8eNk", "uri": "/contracts/i7tEJHG8eNk#development-and-commercialization-responsibilities", "label": "License and Commercialization Agreement (Otonomy, Inc.)", "score": 25.4626960754, "published": true}], "size": 2, "snippet_links": [{"key": "pay-for", "type": "definition", "offset": [62, 69]}, {"key": "all-costs", "type": "definition", "offset": [70, 79]}, {"key": "responsibility-for", "type": "clause", "offset": [110, 128]}, {"key": "the-development", "type": "clause", "offset": [129, 144]}, {"key": "sale-of-the", "type": "clause", "offset": [178, 189]}, {"key": "activities-related-to", "type": "clause", "offset": [370, 391]}, {"key": "in-the-territory", "type": "clause", "offset": [412, 428]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [503, 538]}, {"key": "to-develop", "type": "definition", "offset": [539, 549]}, {"key": "obtain-approvals", "type": "clause", "offset": [551, 567]}, {"key": "affiliates-and-sublicensees", "type": "clause", "offset": [701, 728]}], "hash": "a80bef6ac8afe2f93754b65dd7d82453", "id": 3}, {"snippet": "Except as expressly set forth herein or otherwise agreed upon by the Parties in writing on a case-by-case basis, Celularity or its sublicensee(s) shall be solely responsible for all development, pre-clinical and clinical testing of the Licensed Products and preparation and filing of all Regulatory Materials and any other documents required in connection with seeking and obtaining Regulatory Approval of the Licensed Products, at Celularity\u2019s or its sublicensee\u2019s (as applicable) sole cost and expense. Notwithstanding the foregoing, Sorrento may provide Celularity with certain assistance in connection with such development and testing activities and obtaining Regulatory Approval, provided that any such services shall be subject to and governed by a separate definitive written services agreement to be executed by Sorrento and Celularity (\u201cServices Agreement\u201d). As between the Parties, Celularity shall own all Regulatory Materials submitted by Celularity to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions. Following receipt of Regulatory Approval for a Licensed Product, Celularity or its sublicensee(s) will be solely responsible for all sales, marketing and distribution decisions and costs and related commercialization activities related to such Licensed Product. Notwithstanding anything contained herein to the contrary, nothing contained herein shall prevent or otherwise restrict Sorrento or any of its Affiliates, in connection with the Reserved CD19 Products, from seeking and obtaining Regulatory Approval of Reserved CD19 Products, and as between Celularity and Sorrento, Sorrento shall own all Regulatory Materials submitted by Sorrento or any of its Affiliates to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions.", "samples": [{"hash": "fowPJk0rMB7", "uri": "/contracts/fowPJk0rMB7#development-and-commercialization-responsibilities", "label": "License and Transfer Agreement (GX Acquisition Corp.)", "score": 32.2388763428, "published": true}], "size": 2, "snippet_links": [{"key": "by-the-parties", "type": "clause", "offset": [62, 76]}, {"key": "in-writing", "type": "definition", "offset": [77, 87]}, {"key": "responsible-for", "type": "clause", "offset": [162, 177]}, {"key": "clinical-testing", "type": "clause", "offset": [212, 228]}, {"key": "licensed-products", "type": "definition", "offset": [236, 253]}, {"key": "preparation-and-filing", "type": "clause", "offset": [258, 280]}, {"key": "regulatory-materials", "type": "definition", "offset": [288, 308]}, {"key": "other-documents-required", "type": "clause", "offset": [317, 341]}, {"key": "in-connection-with", "type": "clause", "offset": [342, 360]}, {"key": "approval-of", "type": "definition", "offset": [394, 405]}, {"key": "cost-and-expense", "type": "clause", "offset": [487, 503]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [505, 534]}, {"key": "assistance-in", "type": "definition", "offset": [581, 594]}, {"key": "testing-activities", "type": "definition", "offset": [632, 650]}, {"key": "provided-that", "type": "definition", "offset": [686, 699]}, {"key": "subject-to", "type": "definition", "offset": [727, 737]}, {"key": "a-separate", "type": "definition", "offset": [754, 764]}, {"key": "executed-by", "type": "definition", "offset": [809, 820]}, {"key": "between-the-parties", "type": "clause", "offset": [872, 891]}, {"key": "submitted-by", "type": "clause", "offset": [939, 951]}, {"key": "regulatory-authorities", "type": "definition", "offset": [970, 992]}, {"key": "regulatory-approvals", "type": "definition", "offset": [1001, 1021]}, {"key": "resulting-from", "type": "definition", "offset": [1022, 1036]}, {"key": "receipt-of-regulatory-approval", "type": "clause", "offset": [1065, 1095]}, {"key": "all-sales", "type": "clause", "offset": [1184, 1193]}, {"key": "marketing-and-distribution", "type": "clause", "offset": [1195, 1221]}, {"key": "activities-related-to", "type": "clause", "offset": [1272, 1293]}, {"key": "nothing-contained", "type": "definition", "offset": [1376, 1393]}], "hash": "a23a4922a64e56a4f4db6f1721be2550", "id": 4}, {"snippet": "(a) Sublicensee shall be solely responsible for, and shall bear the entire cost of performing or having performed, all Development of Licensed Compounds and Licensed Products in the Sublicensed Field in the Territory, and all Commercialization of Licensed Products in the Sublicensed Field in the Territory, and the satisfaction of all regulatory requirements with respect thereto. As between the Parties, and subject to the provisions of Article IV. Sublicensee shall assume responsibility for fulfilling the obligations set forth in Article 3 of the Head License for the Sublicensed Field in the Territory.\n(b) Notwithstanding the provisions of Section 2.2(a), neither Party shall file for Regulatory Approval or apply for or seek to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations) with respect to any Licensed Compounds and Licensed Products in any country or jurisdiction in the Territory (the Party first seeking Regulatory Approval, the \u201cFiling Party\u201d), without providing prior written notice to the non-Filing Party. If requested in writing by the non-Filing Party within seven (7) Business Days of receipt of such notice from the Filing Party, the Parties shall discuss the regulatory pathway for the Licensed Compounds and Licensed Products in the Territory, and the Parties shall agree whether or not the Filing Party will file for Regulatory Approval and which Party shall be responsible for listings in the FDA\u2019s Orange Book, and under similar or equivalent laws in other countries or jurisdictions in the Territory, seeking to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations), and for which Patents the Parties will file patent term extensions; provided, however, that in the event the Parties are not able to agree to any of the foregoing within a period of thirty (30) days following the date of receipt of the initial notice provided to the non-Filing Party, Sublicensor shall make the final determination in respect thereto; provided, such determination must be reasonable under the then-existing circumstances. Without limiting the foregoing, neither Party shall be required to provide legally privileged or commercially sensitive information in connection with the foregoing items unless and until procedures reasonably acceptable to the Party making such disclosure are in place to protect such privilege or information exchange.", "samples": [{"hash": "3yTzBZ2RIHu", "uri": "/contracts/3yTzBZ2RIHu#development-and-commercialization-responsibilities", "label": "Sublicense Agreement (Dermavant Sciences LTD)", "score": 30.1882266998, "published": true}], "size": 2, "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [32, 47]}, {"key": "cost-of", "type": "definition", "offset": [75, 82]}, {"key": "development-of", "type": "clause", "offset": [119, 133]}, {"key": "licensed-compounds-and-licensed-products", "type": "clause", "offset": [134, 174]}, {"key": "sublicensed-field", "type": "definition", "offset": [182, 199]}, {"key": "in-the-territory", "type": "clause", "offset": [200, 216]}, {"key": "commercialization-of-licensed-products", "type": "clause", "offset": [226, 264]}, {"key": "satisfaction-of", "type": "clause", "offset": [316, 331]}, {"key": "regulatory-requirements", "type": "definition", "offset": [336, 359]}, {"key": "between-the-parties", "type": "clause", "offset": [385, 404]}, {"key": "article-iv", "type": "definition", "offset": [439, 449]}, {"key": "responsibility-for", "type": "clause", "offset": [476, 494]}, {"key": "the-obligations", "type": "clause", "offset": [506, 521]}, {"key": "article-3", "type": "definition", "offset": [535, 544]}, {"key": "head-license", "type": "definition", "offset": [552, 564]}, {"key": "the-provisions-of-section", "type": "clause", "offset": [629, 654]}, {"key": "neither-party-shall", "type": "clause", "offset": [663, 682]}, {"key": "regulatory-approval", "type": "definition", "offset": [692, 711]}, {"key": "accelerated-approval", "type": "definition", "offset": [783, 803]}, {"key": "priority-review-voucher", "type": "definition", "offset": [805, 828]}, {"key": "orphan-drug", "type": "definition", "offset": [861, 872]}, {"key": "rare-disease", "type": "definition", "offset": [874, 886]}, {"key": "with-respect-to", "type": "clause", "offset": [973, 988]}, {"key": "the-party", "type": "clause", "offset": [1083, 1092]}, {"key": "filing-party", "type": "definition", "offset": [1133, 1145]}, {"key": "the-non", "type": "clause", "offset": [1191, 1198]}, {"key": "in-writing", "type": "definition", "offset": [1226, 1236]}, {"key": "receipt-of", "type": "clause", "offset": [1295, 1305]}, {"key": "the-parties-shall", "type": "clause", "offset": [1341, 1358]}, {"key": "be-responsible", "type": "clause", "offset": [1573, 1587]}, {"key": "the-fda", "type": "clause", "offset": [1604, 1611]}, {"key": "orange-book", "type": "definition", "offset": [1614, 1625]}, {"key": "or-equivalent", "type": "definition", "offset": [1645, 1658]}, {"key": "other-countries", "type": "clause", "offset": [1667, 1682]}, {"key": "seeking-to-obtain", "type": "definition", "offset": [1718, 1735]}, {"key": "the-parties-will", "type": "clause", "offset": [1989, 2005]}, {"key": "patent-term-extensions", "type": "definition", "offset": [2011, 2033]}, {"key": "in-the-event-the", "type": "clause", "offset": [2059, 2075]}, {"key": "parties-are", "type": "clause", "offset": [2076, 2087]}, {"key": "agree-to", "type": "clause", "offset": [2100, 2108]}, {"key": "period-of", "type": "clause", "offset": [2139, 2148]}, {"key": "the-date-of-receipt", "type": "clause", "offset": [2176, 2195]}, {"key": "notice-provided", "type": "clause", "offset": [2211, 2226]}, {"key": "the-final-determination", "type": "definition", "offset": [2275, 2298]}, {"key": "such-determination", "type": "definition", "offset": [2329, 2347]}, {"key": "without-limiting-the-foregoing", "type": "clause", "offset": [2406, 2436]}, {"key": "to-provide", "type": "definition", "offset": [2470, 2480]}, {"key": "commercially-sensitive-information", "type": "clause", "offset": [2503, 2537]}, {"key": "in-connection-with", "type": "clause", "offset": [2538, 2556]}, {"key": "in-place", "type": "definition", "offset": [2667, 2675]}, {"key": "information-exchange", "type": "definition", "offset": [2705, 2725]}], "hash": "84fbc3f5ec99d8ed9f64b4a298f2f69e", "id": 5}, {"snippet": "Subject to paragraph (a), the Licensee will comply with the current Development Plan including all timeframes set out in the Development Plan. Licensee shall have the sole right and control over, all of its development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Field and in the Territory. Licensee will update the Development Plan and provide a copy of the same to the Licensor at least once every six (6) months. The format of such updated Development Plan shall be no less detailed than, and consistent with the format of, the version annexed at Schedule 1 at the Effective Date, unless agreed otherwise by the Parties.\n(a) Licensee may request in writing that Licensor consent to revise the applicable time within which to attain a Key Milestone if supported by evidence of technical difficulties or delays in pre-clinical, clinical studies or regulatory processes that are outside of Licensee\u2019s reasonable control, including, but not limited to, any delay that would result (a) from emerging safety issues causing the clinical program to be put on hold by a regulatory agency or sponsor and/or mandate before further preclinical works be conducted, (b) from a poor pharmacokinetic or pharmacodynamic profile or efficacy in man that would require further formulation or preclinical development to be conducted, (c) from any administrative issues in preclinical or clinical trial conduct (e.g. contract research or manufacturing organization failing to deliver work in due time, delays in patient recruitments), or (d) from preclinical or clinical findings requiring further investigations to be conducted. The parties will discuss any such request in good faith and Licensor will not unreasonably deny a request for appropriate extension provided that sufficient objective evidence of the nature set forth above is provided.", "samples": [{"hash": "scwr2tfTun", "uri": "/contracts/scwr2tfTun#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement (Radiopharm Theranostics LTD)", "score": 34.1170425415, "published": true}], "size": 1, "snippet_links": [{"key": "subject-to", "type": "definition", "offset": [0, 10]}, {"key": "the-licensee-will", "type": "clause", "offset": [26, 43]}, {"key": "current-development-plan", "type": "definition", "offset": [60, 84]}, {"key": "set-out", "type": "definition", "offset": [110, 117]}, {"key": "the-development-plan", "type": "clause", "offset": [121, 141]}, {"key": "licensee-shall", "type": "clause", "offset": [143, 157]}, {"key": "commercialization-activities", "type": "definition", "offset": [238, 266]}, {"key": "regulatory-activities", "type": "clause", "offset": [282, 303]}, {"key": "with-respect-to", "type": "clause", "offset": [305, 320]}, {"key": "licensed-products", "type": "definition", "offset": [321, 338]}, {"key": "in-the-field", "type": "clause", "offset": [339, 351]}, {"key": "in-the-territory", "type": "clause", "offset": [356, 372]}, {"key": "a-copy-of-the", "type": "clause", "offset": [428, 441]}, {"key": "the-licensor", "type": "clause", "offset": [450, 462]}, {"key": "updated-development-plan", "type": "definition", "offset": [518, 542]}, {"key": "consistent-with-the", "type": "clause", "offset": [579, 598]}, {"key": "schedule-1", "type": "definition", "offset": [633, 643]}, {"key": "at-the-effective-date", "type": "clause", "offset": [644, 665]}, {"key": "unless-agreed-otherwise", "type": "clause", "offset": [667, 690]}, {"key": "by-the-parties", "type": "clause", "offset": [691, 705]}, {"key": "licensee-may", "type": "clause", "offset": [711, 723]}, {"key": "request-in-writing", "type": "clause", "offset": [724, 742]}, {"key": "consent-to", "type": "definition", "offset": [757, 767]}, {"key": "applicable-time", "type": "definition", "offset": [779, 794]}, {"key": "key-milestone", "type": "definition", "offset": [820, 833]}, {"key": "evidence-of", "type": "clause", "offset": [850, 861]}, {"key": "technical-difficulties", "type": "clause", "offset": [862, 884]}, {"key": "clinical-studies", "type": "definition", "offset": [912, 928]}, {"key": "of-licensee", "type": "clause", "offset": [970, 981]}, {"key": "reasonable-control", "type": "clause", "offset": [984, 1002]}, {"key": "not-limited", "type": "clause", "offset": [1019, 1030]}, {"key": "safety-issues", "type": "definition", "offset": [1081, 1094]}, {"key": "clinical-program", "type": "clause", "offset": [1107, 1123]}, {"key": "on-hold", "type": "definition", "offset": [1134, 1141]}, {"key": "regulatory-agency", "type": "clause", "offset": [1147, 1164]}, {"key": "preclinical-development", "type": "definition", "offset": [1358, 1381]}, {"key": "administrative-issues", "type": "clause", "offset": [1412, 1433]}, {"key": "trial-conduct", "type": "clause", "offset": [1461, 1474]}, {"key": "contract-research", "type": "definition", "offset": [1481, 1498]}, {"key": "due-time", "type": "definition", "offset": [1556, 1564]}, {"key": "the-parties-will", "type": "clause", "offset": [1694, 1710]}, {"key": "in-good-faith", "type": "clause", "offset": [1736, 1749]}, {"key": "licensor-will", "type": "clause", "offset": [1754, 1767]}, {"key": "request-for", "type": "definition", "offset": [1792, 1803]}, {"key": "provided-that", "type": "definition", "offset": [1826, 1839]}, {"key": "objective-evidence", "type": "definition", "offset": [1851, 1869]}, {"key": "the-nature", "type": "clause", "offset": [1873, 1883]}], "hash": "ef2cbe9d2c56390bc13de73d5be61353", "id": 6}, {"snippet": "Subject to Section 3.1, all decisions concerning the Research, Development, Manufacture and Commercialization of the Licensed Product, including the clinical and regulatory strategy of the Licensed Product, the marketing and sales of the Licensed Product, and the design, price, and promotion of the Licensed Product, shall be at the sole discretion of Fulcrum. If Fulcrum reasonably requests assistance or input from CAMP4 with respect to Research or Development activities being undertaken by Fulcrum in respect of a Licensed Product, CAMP4 shall (at Fulcrum\u2019s expense), use its Commercially Reasonable Efforts to cooperate in good faith with Fulcrum in response to such request (e.g., by responding to regulatory inquiries relating to the pre-clinical development of a Licensed Product by CAMP4, intellectual property matters with respect to Licensed Patents and Know-How, etc.).", "samples": [{"hash": "cJnStLT9nNb", "uri": "/contracts/cJnStLT9nNb#development-and-commercialization-responsibilities", "label": "License Agreement (Fulcrum Therapeutics, Inc.)", "score": 34.8480491638, "published": true}], "size": 1, "snippet_links": [{"key": "section-31", "type": "definition", "offset": [11, 22]}, {"key": "the-research", "type": "clause", "offset": [49, 61]}, {"key": "commercialization-of-the-licensed-product", "type": "clause", "offset": [92, 133]}, {"key": "regulatory-strategy", "type": "definition", "offset": [162, 181]}, {"key": "marketing-and-sales", "type": "clause", "offset": [211, 230]}, {"key": "the-design", "type": "clause", "offset": [260, 270]}, {"key": "sole-discretion", "type": "definition", "offset": [334, 349]}, {"key": "with-respect-to", "type": "clause", "offset": [424, 439]}, {"key": "development-activities", "type": "definition", "offset": [452, 474]}, {"key": "by-fulcrum", "type": "clause", "offset": [492, 502]}, {"key": "in-respect-of", "type": "definition", "offset": [503, 516]}, {"key": "reasonable-efforts-to-cooperate", "type": "clause", "offset": [594, 625]}, {"key": "in-good-faith", "type": "clause", "offset": [626, 639]}, {"key": "responding-to", "type": "clause", "offset": [691, 704]}, {"key": "regulatory-inquiries", "type": "clause", "offset": [705, 725]}, {"key": "relating-to", "type": "definition", "offset": [726, 737]}, {"key": "the-pre", "type": "clause", "offset": [738, 745]}, {"key": "development-of-a", "type": "clause", "offset": [755, 771]}, {"key": "intellectual-property-matters", "type": "definition", "offset": [799, 828]}, {"key": "licensed-patents", "type": "clause", "offset": [845, 861]}], "hash": "fae2f658df82bc35474d9d779767dca6", "id": 7}, {"snippet": "(i) During the term of this Agreement, Sorrento shall have sole control over all Licensed Products in the Field in the Territory. As between the Parties, following receipt of Regulatory Approval for a Licensed Product, and subject to ACEA\u2019s obligation to supply Product Materials to Sorrento as provided hereunder or pursuant to one or more Supply Agreements (including CMC and clinical development obligations), and further subject to any other obligations of ACEA under this Agreement or in any Supply Agreement, Sorrento shall be solely responsible, at its own expense, for all aspects of the development (including, but not limited to, chemistry manufacturing controls, and clinical development), manufacture, registration and commercialization (including, but not limited to, marketing, promoting, selling, distributing and determining pricing) of such Licensed Product in the Field in the Territory.\n(ii) Sorrento shall make Commercially Reasonable Efforts to commercialize the Licensed Products. As between the Parties, and subject to ACEA\u2019s obligation to supply Product Materials to Sorrento as provided hereunder or pursuant to one or more Supply Agreements, and further subject to any other obligations of ACEA under this Agreement or in any Supply Agreement (including CMC and clinical development obligations), Sorrento shall conduct all activities relating to the commercialization of the Licensed Products in the Field within the Territory at its own expense.", "samples": [{"hash": "hNJ6fh8CWrb", "uri": "/contracts/hNJ6fh8CWrb#development-and-commercialization-responsibilities", "label": "License Agreement (Sorrento Therapeutics, Inc.)", "score": 31.8555774689, "published": true}], "size": 1, "snippet_links": [{"key": "during-the-term-of-this-agreement", "type": "clause", "offset": [4, 37]}, {"key": "sole-control", "type": "clause", "offset": [59, 71]}, {"key": "all-licensed-products", "type": "definition", "offset": [77, 98]}, {"key": "in-the-field", "type": "clause", "offset": [99, 111]}, {"key": "between-the-parties", "type": "clause", "offset": [133, 152]}, {"key": "receipt-of-regulatory-approval", "type": "clause", "offset": [164, 194]}, {"key": "subject-to", "type": "definition", "offset": [223, 233]}, {"key": "obligation-to-supply", "type": "clause", "offset": [241, 261]}, {"key": "product-materials", "type": "definition", "offset": [262, 279]}, {"key": "pursuant-to", "type": "definition", "offset": [317, 328]}, {"key": "supply-agreements", "type": "definition", "offset": [341, 358]}, {"key": "development-obligations", "type": "definition", "offset": [387, 410]}, {"key": "obligations-of", "type": "clause", "offset": [446, 460]}, {"key": "agreement-or", "type": "definition", "offset": [477, 489]}, {"key": "the-development", "type": "clause", "offset": [592, 607]}, {"key": "not-limited", "type": "clause", "offset": [624, 635]}, {"key": "commercially-reasonable-efforts-to-commercialize", "type": "clause", "offset": [931, 979]}, {"key": "relating-to", "type": "definition", "offset": [1361, 1372]}, {"key": "commercialization-of-the-licensed-products", "type": "clause", "offset": [1377, 1419]}, {"key": "within-the-territory", "type": "clause", "offset": [1433, 1453]}], "hash": "4efc757e14b46c7877a1c36602113d88", "id": 8}, {"snippet": "During the Term, Curis shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities, including all regulatory activities, with respect to Licensed Products, at Curis\u2019 sole cost and expense.", "samples": [{"hash": "7g0eDqy83XT", "uri": "/contracts/7g0eDqy83XT#development-and-commercialization-responsibilities", "label": "Exclusive License Agreement (Curis Inc)", "score": 24.1950721741, "published": true}], "size": 1, "snippet_links": [{"key": "during-the-term", "type": "clause", "offset": [0, 15]}, {"key": "responsibility-for", "type": "clause", "offset": [53, 71]}, {"key": "commercialization-activities", "type": "definition", "offset": [136, 164]}, {"key": "regulatory-activities", "type": "clause", "offset": [180, 201]}, {"key": "with-respect-to", "type": "clause", "offset": [203, 218]}, {"key": "licensed-products", "type": "definition", "offset": [219, 236]}, {"key": "cost-and-expense", "type": "clause", "offset": [253, 269]}], "hash": "927acb3113b2bc4f8ca7c65fdad299c9", "id": 9}, {"snippet": "(a) Disc shall be responsible for all Development and Commercialization activities with respect to Licensed Antibodies and Licensed Products in the Licensed Territory. Mabwell shall be responsible for all Development and Commercialization activities with respect to Licensed Antibodies and Licensed Products in the Mabwell Territory. Disc shall have the right to generate, or otherwise make or Exploit any Combination Product in the Licensed Territory solely in accordance with the following: if Disc desires to generate, or otherwise make or Exploit any Combination Product, Disc shall promptly notify Mabwell in writing, including the other active pharmaceutical ingredient being incorporated in such Combination Product and any proposed update to the Development Plan with respect thereto. Disc shall have the right to generate, or otherwise make or Exploit such Combination Product pursuant to the Development Plan, as amended from time to time pursuant to Section 2.2(c).\n(b) All Development of each Licensed Antibody and Licensed Product by or on behalf of Disc under this Agreement will be conducted pursuant to a written development plan that sets forth, in reasonable detail, all pre-clinical, clinical and regulatory activities (and the anticipated timelines) to be conducted by or on behalf of Discs to obtain Regulatory Approval of at least one Licensed Product in the Licensed Territory (including but not limited to the Major Markets) (the \u201cDevelopment Plan\u201d). As of the Effective Date, the Parties have agreed on the initial Development Plan, which is attached hereto as Schedule 2.2(b). From time to time, but at least [***], Disc will propose updates or amendments to the Development Plan in consultation with the JSC and submit such proposed updated or amended plan to the JSC for its review and approval before adopting such update or amendment. Disc shall also provide to Mabwell, via the JSC, a reasonably detailed clinical development plan, including the protocols and dosing regimen for all clinical trials of the Licensed Products to be conducted by or behalf of Disc and all investigator-sponsored and investigator-initiated trials of the Licensed Products in the Licensed Territory(the \u201cClinical Development Plan\u201d), in each case prior to any patient enrollment, for review and approval by the JSC.\n(c) All Commercialization of each Licensed Antibody and Licensed Product by or on behalf of Disc will be conducted, pursuant to a written plan that sets forth in reasonable detail, the commercialization activities for such Licensed Product in the Licensed Territory (the \u201cCommercialization Plan\u201d), including commercialization strategy, marketing and sales strategy. On a Licensed Product-by-Licensed Product basis, Disc will prepare and submit to the JSC an initial Commercialization Plan for review and approval no later than [***] before the anticipated date of Regulatory Approval for such Licensed Product in the Field in the Licensed Territory. In addition, Disc shall also provide to Mabwell, via the JSC, a two-year sales forecast for such Licensed Product concurrent with such initial Commercialization Plan (to be updated on an annual rolling basis). From time to time, but at least annually, Disc will prepare updates or amendments to the Commercialization Plan, and will submit such update or amendment to the JSC review and approval before adopting such update or amendment. Specifically and without limiting the foregoing, Disc shall timely carry out all Commercialization activities set forth in and in accordance with the Commercialization Plan. Disc will keep Mabwell reasonably informed of its, its Affiliates\u2019 and Sublicensees\u2019 Commercialization activities with respect to the Licensed Products in the Licensed Territory. Without limiting the foregoing, Disc will provide Mabwell, through the JSC, with a commercialization report at least [***] regarding the Commercialization activities with respect to all Licensed Products in each Indication in the Licensed Territory, and will make available to Mabwell such additional information about its Commercialization activities as may be reasonably requested by Mabwell from time to time.\n(d) On at least [***] basis, through the JSC, Mabwell shall provide to Disc a written copy of Mabwell\u2019s high level plans (which shall include, for the avoidance of doubt, development plans, clinical trial plans, planned filings of Regulatory Documentation with a Regulatory Authority and commercialization plans) for the Development and Commercialization of the Licensed Antibodies and Licensed Products in each Indication in the Mabwell Territory.", "samples": [{"hash": "fDr5UticaAV", "uri": "/contracts/fDr5UticaAV#development-and-commercialization-responsibilities", "label": 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