{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "by-the-parties", "type": "clause", "offset": [24, 38]}, {"key": "lead-product", "type": "definition", "offset": [94, 106]}, {"key": "nine-months", "type": "definition", "offset": [130, 141]}, {"key": "exercise-of-the-option", "type": "clause", "offset": [174, 196]}, {"key": "other-licensed-product", "type": "definition", "offset": [219, 241]}, {"key": "article-8", "type": "definition", "offset": [256, 265]}, {"key": "manufacturing-and-supply", "type": "definition", "offset": [267, 291]}, {"key": "in-accordance-with", "type": "definition", "offset": [301, 319]}, {"key": "section-81", "type": "clause", "offset": [320, 331]}, {"key": "other-time", "type": "clause", "offset": [342, 352]}, {"key": "as-agreed", "type": "clause", "offset": [353, 362]}, {"key": "by-each-party", "type": "clause", "offset": [363, 376]}, {"key": "the-parties-will", "type": "clause", "offset": [379, 395]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [396, 419]}, {"key": "terms-for", "type": "definition", "offset": [482, 491]}, {"key": "roche-territory", "type": "definition", "offset": [555, 570]}, {"key": "supply-price", "type": "definition", "offset": [578, 590]}, {"key": "quality-agreement", "type": "definition", "offset": [643, 660]}, {"key": "terms-and-conditions-of-the", "type": "clause", "offset": [695, 722]}, {"key": "development-purposes", "type": "definition", "offset": [766, 786]}, {"key": "single-agreement", "type": "clause", "offset": [829, 845]}, {"key": "the-development", "type": "clause", "offset": [846, 861]}, {"key": "agreement-for", "type": "clause", "offset": [905, 918]}], "size": 5, "snippet": "Unless otherwise agreed by the Parties, no later than (a) March 31, 2022, with regards to the Lead Product, and (b) no later than nine months following the effective date of exercise of the Option with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of such Licensed Product by Sarepta to Roche in the Roche Territory at the Supply Price (the \u201cDevelopment Supply Agreement\u201d), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of such Licensed Product for Development purposes. The Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product.", "samples": [{"hash": "3ViTVOdaFrz", "uri": "/contracts/3ViTVOdaFrz#development-supply-agreement", "label": "License, Collaboration, and Option Agreement (Sarepta Therapeutics, Inc.)", "score": 31.1615331964, "published": true}], "hash": "1b163d769e0e3eb62853067b49df469b", "id": 1}, {"snippet_links": [{"key": "as-directed", "type": "definition", "offset": [13, 24]}, {"key": "subject-to-the", "type": "definition", "offset": [96, 110]}, {"key": "the-parties-will", "type": "clause", "offset": [133, 149]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [150, 173]}, {"key": "agreement-for", "type": "clause", "offset": [194, 207]}, {"key": "manufacture-and-supply", "type": "clause", "offset": [215, 237]}, {"key": "development-and-clinical", "type": "clause", "offset": [303, 327]}, {"key": "development-of", "type": "clause", "offset": [328, 342]}, {"key": "phase-i", "type": "definition", "offset": [400, 407]}, {"key": "clinical-trial", "type": "clause", "offset": [411, 425]}, {"key": "in-accordance-with", "type": "definition", "offset": [480, 498]}, {"key": "development-quality-assurance-agreement", "type": "definition", "offset": [576, 615]}, {"key": "related-to", "type": "clause", "offset": [682, 692]}, {"key": "rights-and-obligations", "type": "definition", "offset": [699, 721]}, {"key": "the-manufacturer", "type": "definition", "offset": [725, 741]}, {"key": "regulatory-responsible-party", "type": "definition", "offset": [824, 852]}, {"key": "each-party", "type": "clause", "offset": [884, 894]}, {"key": "approval-rights", "type": "definition", "offset": [929, 944]}, {"key": "the-development", "type": "clause", "offset": [958, 973]}, {"key": "provide-for", "type": "clause", "offset": [1044, 1055]}, {"key": "terms-and-conditions", "type": "definition", "offset": [1066, 1086]}, {"key": "quality-requirements", "type": "definition", "offset": [1098, 1118]}, {"key": "objective-criteria", "type": "definition", "offset": [1168, 1186]}, {"key": "related-rights", "type": "clause", "offset": [1213, 1227]}, {"key": "technical-criteria", "type": "definition", "offset": [1263, 1281]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [1337, 1360]}], "size": 4, "snippet": "At such time as directed by the JMC following identification of any Candidates and Products and subject to the oversight of the JMC, the Parties will negotiate in good faith a definitive supply agreement for HMI to Manufacture and supply Candidates and Products to NVS for use in conducting Preclinical Development and Clinical Development of such Candidates and Products until the completion of the Phase I/II Clinical Trial for Candidates and Products that Modulate such Target in accordance with this Agreement (\u201cDevelopment Supply Agreement(s)\u201d) along with the associated Development Quality Assurance Agreement (which Development Quality Assurance Agreement will contain terms related to HMI\u2019s rights and obligations as the Manufacturer of such Product(s) as well as terms related to NVS\u2019 rights and obligations as the Regulatory Responsible Party for such Product(s), including each Party\u2019s respective review, comment, and approval rights thereunder). The Development Supply Agreement and the Development Quality Assurance Agreement will provide for customary terms and conditions, including quality requirements, those provisions required under Sections 8.1.3 (Objective Criteria) and 8.6.1 (Manufacturing Related Rights), forecasting, ordering, delivery, technical criteria to be met, payment, and supply, in accordance with the terms of this Agreement.", "samples": [{"hash": "Q2QFJpa3hi", "uri": "/contracts/Q2QFJpa3hi#development-supply-agreement", "label": "Collaboration and License Agreement (Homology Medicines, Inc.)", "score": 29.2217659138, "published": true}, {"hash": "kayjChU2uZp", "uri": "/contracts/kayjChU2uZp#development-supply-agreement", "label": "Collaboration and License Agreement (Homology Medicines, Inc.)", "score": 29.2108145106, "published": true}, {"hash": "6rYmvPxNCPe", "uri": "/contracts/6rYmvPxNCPe#development-supply-agreement", "label": "Collaboration and License Agreement (Homology Medicines, Inc.)", "score": 29.1642710472, "published": true}], "hash": "ea0a85052b2a823116709faf7613187b", "id": 2}, {"snippet_links": [{"key": "after-the-effective-date", "type": "clause", "offset": [20, 44]}, {"key": "the-parties-will", "type": "clause", "offset": [46, 62]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [63, 86]}, {"key": "technical-transfer-agreement", "type": "definition", "offset": [115, 143]}, {"key": "pursuant-to", "type": "definition", "offset": [181, 192]}, {"key": "terms-of", "type": "definition", "offset": [231, 239]}, {"key": "section-53", "type": "clause", "offset": [240, 251]}, {"key": "promptly-provide", "type": "clause", "offset": [253, 269]}, {"key": "third-party-contract", "type": "clause", "offset": [279, 299]}, {"key": "reasonably-necessary", "type": "clause", "offset": [393, 413]}, {"key": "bulk-drug-substance", "type": "definition", "offset": [451, 470]}, {"key": "bulk-drug-product", "type": "definition", "offset": [472, 489]}, {"key": "finished-product", "type": "definition", "offset": [494, 510]}, {"key": "the-case", "type": "definition", "offset": [515, 523]}, {"key": "make-available", "type": "definition", "offset": [542, 556]}, {"key": "reasonable-basis", "type": "definition", "offset": [576, 592]}, {"key": "to-consult", "type": "definition", "offset": [593, 603]}, {"key": "by-alnylam", "type": "clause", "offset": [694, 704]}, {"key": "in-connection-with", "type": "clause", "offset": [705, 723]}, {"key": "technology-transfer-activities", "type": "definition", "offset": [729, 759]}, {"key": "the-development", "type": "clause", "offset": [866, 881]}, {"key": "commercially-reasonable", "type": "clause", "offset": [908, 931]}, {"key": "consistent-with", "type": "clause", "offset": [936, 951]}, {"key": "industry-standards", "type": "definition", "offset": [952, 970]}, {"key": "if-applicable", "type": "clause", "offset": [984, 997]}, {"key": "contract-manufacturers", "type": "definition", "offset": [1041, 1063]}, {"key": "this-exhibit", "type": "definition", "offset": [1098, 1110]}, {"key": "replaced-with", "type": "clause", "offset": [1128, 1141]}, {"key": "the-secretary", "type": "clause", "offset": [1217, 1230]}, {"key": "the-securities-and-exchange-commission", "type": "clause", "offset": [1234, 1272]}, {"key": "confidential-treatment", "type": "definition", "offset": [1311, 1333]}, {"key": "under-rule", "type": "clause", "offset": [1334, 1344]}, {"key": "securities-exchange-act-of-1934", "type": "clause", "offset": [1358, 1389]}], "size": 3, "snippet": "Within [***] months after the Effective Date, the Parties will negotiate in good faith and enter into a supply and technical transfer agreement (the \u201cDevelopment Supply Agreement\u201d) pursuant to which Alnylam will (a) subject to the terms of Section 5.3, promptly provide MedCo or Third Party contract manufacturer(s) selected by MedCo and reasonably acceptable to Alnylam with Alnylam Know-How reasonably necessary or useful for the Manufacture of the Bulk Drug Substance, Bulk Drug Product and Finished Product, as the case may be, and shall make available its personnel on a reasonable basis to consult with MedCo with respect thereto, all at MedCo\u2019s expense for the Costs reasonably incurred by Alnylam in connection with such technology transfer activities; and (b) supply Finished Product to MedCo as set forth in Section 5.1(a)(ii). The terms and conditions of the Development Supply Agreement shall be commercially reasonable and consistent with industry standards, as well as, if applicable, Alnylam\u2019s agreements with its Third Party contract manufacturers. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH \u201c[***]\u201d. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.", "samples": [{"hash": "h4IzP3EHexR", "uri": "/contracts/h4IzP3EHexR#development-supply-agreement", "label": "License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)", "score": 24.5646817248, "published": true}, {"hash": "iIQg2ToI693", "uri": "/contracts/iIQg2ToI693#development-supply-agreement", "label": "License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)", "score": 24.3456536619, "published": true}], "hash": "970b9a19652ffbff482096b028d4af49", "id": 3}, {"snippet_links": [{"key": "as-directed", "type": "definition", "offset": [13, 24]}, {"key": "the-parties-will", "type": "clause", "offset": [37, 53]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [54, 77]}, {"key": "the-development", "type": "clause", "offset": [91, 106]}, {"key": "quality-agreement", "type": "definition", "offset": [139, 156]}, {"key": "terms-and-conditions-of-the", "type": "clause", "offset": [191, 218]}, {"key": "development-purposes", "type": "definition", "offset": [271, 291]}, {"key": "provided-that", "type": "clause", "offset": [293, 306]}, {"key": "development-activities", "type": "clause", "offset": [361, 383]}, {"key": "prior-to-the", "type": "clause", "offset": [384, 396]}, {"key": "entering-into", "type": "clause", "offset": [405, 418]}, {"key": "batch-basis", "type": "definition", "offset": [522, 533]}, {"key": "supply-price", "type": "definition", "offset": [592, 604]}, {"key": "the-principles", "type": "clause", "offset": [743, 757]}, {"key": "on-schedule", "type": "definition", "offset": [768, 779]}, {"key": "key-terms", "type": "definition", "offset": [814, 823]}], "size": 2, "snippet": "At such time as directed by the JSC, the Parties will negotiate in good faith the terms of the Development Supply Agreement, and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of the MG Manufactured Components for Development purposes; provided that if Ionis needs any MG Manufactured Components for its Development activities prior to the Parties entering into the Development Supply Agreement, then Metagenomi will supply such MG Manufactured Components on a per-batch basis and Ionis will pay Metagenomi on a per-batch basis at the Supply Price for each such batch. The Development Supply Agreement and the related quality agreement will include terms and conditions consistent with the principles set forth on Schedule 8.2 (Development Supply Agreement Key Terms).", "samples": [{"hash": "b56F5Ko0KXQ", "uri": "/contracts/b56F5Ko0KXQ#development-supply-agreement", "label": "Collaboration and License Agreement (Metagenomi Technologies, LLC)", "score": 35.0095824778, "published": true}, {"hash": "hp4L7o4f5KY", "uri": "/contracts/hp4L7o4f5KY#development-supply-agreement", "label": "Collaboration and License Agreement (Ionis Pharmaceuticals Inc)", "score": 34.1416837782, "published": true}], "hash": "e24dd6b43416a5c40ee5509b10e79334", "id": 4}, {"snippet_links": [{"key": "after-the-effective-date", "type": "clause", "offset": [19, 43]}, {"key": "the-parties-will", "type": "clause", "offset": [45, 61]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [62, 85]}, {"key": "technical-transfer-agreement", "type": "definition", "offset": [114, 142]}, {"key": "pursuant-to", "type": "definition", "offset": [180, 191]}, {"key": "terms-of", "type": "definition", "offset": [230, 238]}, {"key": "section-53", "type": "clause", "offset": [239, 250]}, {"key": "promptly-provide", "type": "clause", "offset": [252, 268]}, {"key": "third-party-contract", "type": "clause", "offset": [278, 298]}, {"key": "reasonably-necessary", "type": "clause", "offset": [392, 412]}, {"key": "bulk-drug-substance", "type": "definition", "offset": [450, 469]}, {"key": "bulk-drug-product", "type": "definition", "offset": [471, 488]}, {"key": "finished-product", "type": "definition", "offset": [493, 509]}, {"key": "the-case", "type": "definition", "offset": [514, 522]}, {"key": "make-available", "type": "definition", "offset": [541, 555]}, {"key": "reasonable-basis", "type": "definition", "offset": [575, 591]}, {"key": "to-consult", "type": "definition", "offset": [592, 602]}, {"key": "by-alnylam", "type": "clause", "offset": [693, 703]}, {"key": "in-connection-with", "type": "clause", "offset": [704, 722]}, {"key": "technology-transfer-activities", "type": "definition", "offset": [728, 758]}, {"key": "the-development", "type": "clause", "offset": [865, 880]}, {"key": "commercially-reasonable", "type": "clause", "offset": [907, 930]}, {"key": "consistent-with", "type": "clause", "offset": [935, 950]}, {"key": "industry-standards", "type": "definition", "offset": [951, 969]}, {"key": "if-applicable", "type": "clause", "offset": [983, 996]}, {"key": "contract-manufacturers", "type": "definition", "offset": [1040, 1062]}], "size": 2, "snippet": "Within [**] months after the Effective Date, the Parties will negotiate in good faith and enter into a supply and technical transfer agreement (the \u201cDevelopment Supply Agreement\u201d) pursuant to which Alnylam will (a) subject to the terms of Section 5.3, promptly provide MedCo or Third Party contract manufacturer(s) selected by MedCo and reasonably acceptable to Alnylam with Alnylam Know-How reasonably necessary or useful for the Manufacture of the Bulk Drug Substance, Bulk Drug Product and Finished Product, as the case may be, and shall make available its personnel on a reasonable basis to consult with MedCo with respect thereto, all at MedCo's expense for the Costs reasonably incurred by Alnylam in connection with such technology transfer activities; and (b) supply Finished Product to MedCo as set forth in Section 5.1(a)(ii). The terms and conditions of the Development Supply Agreement shall be commercially reasonable and consistent with industry standards, as well as, if applicable, Alnylam's agreements with its Third Party contract manufacturers.", "samples": [{"hash": "4SVjVAlSNkT", "uri": "/contracts/4SVjVAlSNkT#development-supply-agreement", "label": "License and Collaboration Agreement (Medicines Co /De)", "score": 24.5619438741, "published": true}, {"hash": "ibRF7GtYUfB", "uri": "/contracts/ibRF7GtYUfB#development-supply-agreement", "label": "License and Collaboration Agreement (Medicines Co /De)", "score": 24.3538672142, "published": true}], "hash": "a0f10bad9487598a101aff949be767d8", "id": 5}, {"snippet_links": [{"key": "following-the-effective-date", "type": "clause", "offset": [13, 41]}, {"key": "by-the-parties", "type": "clause", "offset": [84, 98]}, {"key": "the-parties-shall", "type": "clause", "offset": [101, 118]}, {"key": "agreement-for", "type": "clause", "offset": [164, 177]}, {"key": "clinical-supply-requirements", "type": "definition", "offset": [215, 243]}, {"key": "development-activities", "type": "clause", "offset": [273, 295]}, {"key": "the-development", "type": "clause", "offset": [330, 345]}, {"key": "provide-for", "type": "clause", "offset": [369, 380]}, {"key": "terms-and-conditions", "type": "definition", "offset": [391, 411]}, {"key": "the-terms", "type": "definition", "offset": [506, 515]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [550, 573]}, {"key": "an-affiliate", "type": "clause", "offset": [599, 611]}, {"key": "to-enter", "type": "definition", "offset": [612, 620]}], "size": 2, "snippet": "Within [***] following the Effective Date (or such other timeframe as may be agreed by the Parties), the Parties shall negotiate and enter into a definitive supply agreement for Regeneron\u2019s supply to Kiniksa of its Clinical Supply Requirements solely for use in conducting Development activities (\u201cDevelopment Supply Agreement\u201d). The Development Supply Agreement shall provide for customary terms and conditions, including forecasting, ordering, delivery, payment, and supply, and shall be consistent with the terms set forth in Schedule 8.3 and the terms of this Agreement. Regeneron may designate an Affiliate to enter into the Development Supply Agreement.", "samples": [{"hash": "gqhnd3pTAW4", "uri": "/contracts/gqhnd3pTAW4#development-supply-agreement", "label": "License Agreement (Kiniksa Pharmaceuticals, Ltd.)", "score": 27.3175906913, "published": true}, {"hash": "fyroviTXbVZ", "uri": "/contracts/fyroviTXbVZ#development-supply-agreement", "label": "License Agreement (Kiniksa Pharmaceuticals, Ltd.)", "score": 27.1560574949, "published": true}], "hash": "90dc9a269534c8f543d48719d04a2b0c", "id": 6}, {"snippet_links": [{"key": "section-74", "type": "clause", "offset": [15, 26]}, {"key": "pursuant-to-a", "type": "definition", "offset": [28, 41]}, {"key": "entered-into", "type": "clause", "offset": [114, 126]}, {"key": "responsible-for", "type": "clause", "offset": [162, 177]}, {"key": "manufacture-and-supply", "type": "clause", "offset": [182, 204]}, {"key": "clinical-trial-materials", "type": "clause", "offset": [212, 236]}, {"key": "development-of-the-product", "type": "clause", "offset": [285, 311]}, {"key": "in-the-field", "type": "clause", "offset": [312, 324]}, {"key": "the-performance", "type": "clause", "offset": [368, 383]}, {"key": "development-activities", "type": "clause", "offset": [398, 420]}, {"key": "the-parties-will", "type": "clause", "offset": [423, 439]}, {"key": "the-development", "type": "clause", "offset": [451, 466]}, {"key": "after-the-effective-date", "type": "clause", "offset": [502, 526]}, {"key": "purchase-price-payable", "type": "clause", "offset": [649, 671]}, {"key": "prior-to-the", "type": "clause", "offset": [833, 845]}, {"key": "technology-transfer", "type": "clause", "offset": [864, 883]}, {"key": "in-accordance-with", "type": "definition", "offset": [942, 960]}, {"key": "agreement-or", "type": "definition", "offset": [984, 996]}, {"key": "agreed-between-the-parties", "type": "clause", "offset": [1017, 1043]}, {"key": "quantity-of", "type": "clause", "offset": [1101, 1112]}, {"key": "clinical-trials", "type": "definition", "offset": [1227, 1242]}, {"key": "approval-of-the-product", "type": "clause", "offset": [1283, 1306]}, {"key": "stability-testing", "type": "clause", "offset": [1382, 1399]}, {"key": "fda-requirements", "type": "clause", "offset": [1487, 1503]}, {"key": "applicable-law", "type": "clause", "offset": [1508, 1522]}, {"key": "as-needed-basis", "type": "definition", "offset": [1621, 1636]}, {"key": "during-the-term", "type": "clause", "offset": [1637, 1652]}, {"key": "by-the-parties", "type": "clause", "offset": [1697, 1711]}, {"key": "cmc-technology", "type": "definition", "offset": [1745, 1759]}, {"key": "related-information", "type": "definition", "offset": [1764, 1783]}], "size": 1, "snippet": "(a) Subject to Section 7.4, pursuant to a development supply agreement (the \u201cDevelopment Supply Agreement\u201d) to be entered into between the Parties, BBIL shall be responsible for the Manufacture and supply of all Clinical Trial Materials required for Ocugen\u2019s non-clinical and clinical Development of the Product in the Field in and for the Ocugen Territory (including the performance of the Ocugen Development Activities). The Parties will enter into the Development Supply Agreement within [***] days after the Effective Date. The Development Supply Agreement shall contain mutually agreeable terms, including, among other things, that the maximum purchase price payable by Ocugen for Clinical Trial Materials manufactured and supplied thereunder shall not exceed [***].\n(b) Except as set forth in the Development Supply Agreement, prior to the completion of the technology transfer as provided in Section 7.3(a), BBIL shall be responsible, in accordance with the Development Supply Agreement or as may otherwise be agreed between the Parties, to (i) Manufacture and supply Ocugen with such form and quantity of Clinical Trial Materials as Ocugen reasonably requires to conduct the Ocugen Development Activities and carry out Clinical Trials necessary to seek and obtain Regulatory Approval of the Product in the Field in and for the Ocugen Territory, and (ii) perform release and stability testing of the Product for use in the Field in and for the Ocugen Territory in accordance with FDA requirements and Applicable Law. In furtherance of the forgoing, within [***] days after the Effective Date, and thereafter on an as needed basis during the Term or as may otherwise be discussed and agreed by the Parties at the JSC, BBIL shall share all CMC Technology and related information for the Product with Ocugen.", "samples": [{"hash": "1u3g6m5LG4a", "uri": "/contracts/1u3g6m5LG4a#development-supply-agreement", "label": "Co Development, Supply and Commercialization Agreement (Ocugen, Inc.)", "score": 32.3456536619, "published": true}], "hash": "b72f59f857c59358952607d50ac6437a", "id": 7}, {"snippet_links": [{"key": "the-development", "type": "clause", "offset": [12, 27]}, {"key": "responsible-for", "type": "clause", "offset": [82, 97]}, {"key": "drug-substance", "type": "definition", "offset": [118, 132]}, {"key": "supply-of-product", "type": "clause", "offset": [137, 154]}, {"key": "clinical-development", "type": "definition", "offset": [185, 205]}, {"key": "meeting-the-specifications", "type": "clause", "offset": [206, 232]}, {"key": "prior-to-the-effective-date", "type": "clause", "offset": [252, 279]}, {"key": "development-in-the-territory", "type": "clause", "offset": [335, 363]}, {"key": "the-parties-will", "type": "clause", "offset": [365, 381]}, {"key": "section-32", "type": "definition", "offset": [405, 416]}, {"key": "for-avoidance-of-doubt", "type": "clause", "offset": [418, 440]}, {"key": "agreed-that", "type": "clause", "offset": [470, 481]}, {"key": "development-of-product", "type": "clause", "offset": [573, 595]}, {"key": "all-costs", "type": "definition", "offset": [607, 616]}, {"key": "omitted-and-filed-separately-with-the-securities-and-exchange-commission", "type": "clause", "offset": [710, 782]}, {"key": "confidential-treatment", "type": "definition", "offset": [784, 806]}, {"key": "with-respect-to", "type": "clause", "offset": [826, 841]}, {"key": "baseline-costs", "type": "definition", "offset": [874, 888]}, {"key": "based-on", "type": "clause", "offset": [893, 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"offset": [1670, 1682]}, {"key": "after-the-effective-date", "type": "clause", "offset": [1728, 1752]}, {"key": "following-the", "type": "definition", "offset": [1779, 1792]}, {"key": "the-parties-shall", "type": "clause", "offset": [1812, 1829]}, {"key": "neutral-arbitrator", "type": "clause", "offset": [1853, 1871]}, {"key": "located-in", "type": "definition", "offset": [1872, 1882]}, {"key": "the-arbitrator", "type": "clause", "offset": [1915, 1929]}, {"key": "by-the-parties", "type": "clause", "offset": [1947, 1961]}, {"key": "manufacturing-and-supply-agreements", "type": "definition", "offset": [2005, 2040]}, {"key": "agreement-on-an-arbitrator", "type": "clause", "offset": [2084, 2110]}, {"key": "each-party-will", "type": "clause", "offset": [2117, 2132]}, {"key": "deliver-to", "type": "definition", "offset": [2247, 2257]}, {"key": "other-party", "type": "definition", "offset": [2281, 2292]}, {"key": "the-opportunity", "type": "clause", "offset": [2433, 2448]}, {"key": "oral-argument", "type": "clause", "offset": [2604, 2617]}, {"key": "evidentiary-hearing", "type": "definition", "offset": [2624, 2643]}, {"key": "assist-the", "type": "clause", "offset": [2687, 2697]}, {"key": "agreement-to", "type": "definition", "offset": [2761, 2773]}, {"key": "business-days", "type": "clause", "offset": [2823, 2836]}, {"key": "after-receipt-of", "type": "clause", "offset": [2837, 2853]}, {"key": "select-one", "type": "clause", "offset": [2956, 2966]}, {"key": "by-both-parties", "type": "clause", "offset": [3176, 3191]}, {"key": "binding-on-the-parties", "type": "clause", "offset": [3196, 3218]}, {"key": "not-modify", "type": "clause", "offset": [3242, 3252]}], "size": 1, "snippet": "Pursuant to the Development Supply Agreement (as defined below), Dermira shall be responsible for the supply of DRM04 drug substance and supply of Product for Maruho\u2019s non-clinical and clinical Development meeting the specifications provided to Maruho prior to the Effective Date ([*****], the \u201cSpecifications\u201d) and if [*****] for the Development in the Territory, the Parties will [*****] as provided by Section 3.2. For avoidance of doubt, the Parties have explicitly agreed that Maruho shall reimburse Dermira for all [*****] incurred by Dermira, in support of Maruho\u2019s Development of Product, including all costs specific only for the Territory. [*****] Certain portions denoted with an asterisk have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Dermira\u2019s baseline costs are based on the [*****] (meeting Dermira\u2019s then-current specifications (the \u201cDermira Specifications\u201d), manufacturing processes, in-process tests, and in-process specifications for Product for Dermira\u2019s development and Commercialization) [*****]. Dermira will notify Maruho of any changes to the Dermira Specifications as soon as reasonably practicable. In addition, the Parties have explicitly agreed that the transfer price of the Product will be Dermira\u2019s [*****] the Product. The Parties will make reasonable effort to execute the supply agreement of supply of DRM04 drug substance and the Product for non-clinical and clinical Development containing the terms set for the on Schedule B (the \u201cDevelopment Supply Agreement\u201d). If the Parties are unable to reach agreement on the terms of the Development Supply Agreement by [*****] days after the Effective Date, then within [*****] days following the end of such period the Parties shall submit the matter to a neutral arbitrator located in London, England as follows: (a) the arbitrator will be selected by the Parties and shall have expertise in pharmaceutical manufacturing and supply agreements (if the Parties are unable to reach mutual agreement on an arbitrator, then each Party will select its neutral arbitrator and the two selected arbitrators shall select the arbitrator), (b) each Party shall deliver to the arbitrator and the other Party its proposed draft of the Development Supply Agreement based on the terms set forth on Schedule B, (c) the arbitrator shall give each Party the opportunity to explain to the arbitrator why its draft of the Development Supply Agreement is more appropriate than the other Party\u2019s, which may include conducting an oral argument or an evidentiary hearing if the arbitrator determines that it would assist the arbitrator\u2019s decision of which draft of the Development Supply Agreement to select, (d) the arbitrator shall, within [*****] Business Days after receipt of the two draft Development Supply Agreements and having heard each Party\u2019s rationale for its proposal, select one draft Development Supply Agreement from the two (2) submitted, that fully reflects the terms set forth on Schedule B and (e) the draft Development Supply Agreement selected by the arbitrator shall be executed by both Parties and binding on the Parties and the arbitrator may not modify or alter the terms of the Development Supply Agreement.", "samples": [{"hash": "61OrMgX79E0", "uri": "/contracts/61OrMgX79E0#development-supply-agreement", "label": "Exclusive License Agreement (Dermira, Inc.)", "score": 27.8501026694, "published": true}], "hash": "d31c779f1ba08d96b96e77d1d8c45203", "id": 8}, {"snippet_links": [{"key": "following-the", "type": "definition", "offset": [34, 47]}, {"key": "agreement-effective-date", "type": "clause", "offset": [66, 90]}, {"key": "the-planned", "type": "clause", "offset": [138, 149]}, {"key": "first-shipment", "type": "definition", "offset": [150, 164]}, {"key": "quantity-of", "type": "clause", "offset": [172, 183]}, {"key": "licensed-product", "type": "clause", "offset": [188, 204]}, {"key": "conduct-of-the", "type": "clause", "offset": [213, 227]}, {"key": "the-parties-shall", "type": "clause", "offset": [241, 258]}, {"key": "the-development", "type": "clause", "offset": [265, 280]}, {"key": "provide-for", "type": "clause", "offset": [301, 312]}, {"key": "each-party", "type": "clause", "offset": [313, 323]}, {"key": "rights-and-responsibilities", "type": "clause", "offset": [326, 353]}, {"key": "with-respect-to-company", "type": "clause", "offset": [354, 377]}, {"key": "permitted-subcontractors", "type": "definition", "offset": [424, 448]}, {"key": "exclusive-purchase", "type": "clause", "offset": [450, 468]}], "size": 1, "snippet": "As soon as reasonably practicable following the nHCM Supplemental Agreement Effective Date, and in any event no later than [***] prior to the planned first shipment of any quantity of the Licensed Product for the conduct of the China Study, the Parties shall amend the Development Supply Agreement to provide for each Party\u2019s rights and responsibilities with respect to Company\u2019s supply, and Licensee\u2019s, its Affiliates\u2019 and Permitted Subcontractors\u2019 exclusive purchase from Company, of Licensed Product for the conduct of the China Study.", "samples": [{"hash": "kKcrZxl5EoW", "uri": "/contracts/kKcrZxl5EoW#development-supply-agreement", "label": "Supplemental Agreement (LianBio)", "score": 34.864476386, "published": true}], "hash": "4e81595757af48095df2a92a9da81947", "id": 9}, {"snippet_links": [{"key": "pursuant-to", "type": "definition", "offset": [0, 11]}, {"key": "entered-into", "type": "clause", "offset": [54, 66]}, {"key": "agreed-to", "type": "clause", "offset": [178, 187]}, {"key": "responsible-for", "type": "clause", "offset": [191, 206]}, {"key": "for-\u2587", "type": "clause", "offset": [226, 231]}, {"key": "clinical-development", "type": "definition", "offset": [256, 276]}, {"key": "meeting-the-specifications", "type": "clause", "offset": [277, 303]}, {"key": "exhibit-a", "type": "clause", "offset": [317, 326]}, {"key": "as-amended", "type": "definition", "offset": [345, 355]}, {"key": "from-time-to-time", "type": "clause", "offset": [356, 373]}, {"key": "by-the-parties", "type": "clause", "offset": [374, 388]}, {"key": "the-parties-acknowledge-and-agree-that", "type": "clause", "offset": [391, 429]}, {"key": "first-restatement-date", "type": "definition", "offset": [440, 462]}, {"key": "the-development", "type": "clause", "offset": [464, 479]}, {"key": "based-on", "type": "clause", "offset": [509, 517]}, {"key": "mutual-agreement", "type": "definition", "offset": [522, 538]}, {"key": "with-respect-to", "type": "clause", "offset": [588, 603]}, {"key": "drug-substance", "type": "definition", "offset": [604, 618]}, {"key": "prior-to-the", "type": "clause", "offset": [661, 673]}, {"key": "the-product", "type": "clause", "offset": [903, 914]}, {"key": "following-the", "type": "definition", "offset": [971, 984]}, {"key": "either-party", "type": "definition", "offset": [1009, 1021]}, {"key": "terms-of", "type": "definition", "offset": [1118, 1126]}, {"key": "agreement-between-the-parties", "type": "clause", "offset": [1149, 1178]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [1201, 1224]}], "size": 1, "snippet": "Pursuant to that certain Development Supply Agreement entered into between the Maruho and Dermira and effective as of March 1, 2017 (the \u201cDevelopment Supply Agreement\u201d), Dermira agreed to be responsible for the supply of [***]for \u2587\u2587\u2587\u2587\u2587\u2587\u2019s non-clinical and clinical Development meeting the specifications set forth in Exhibit A attached thereto (as amended from time to time by the Parties). The Parties acknowledge and agree that as of the First Restatement Date, the Development Supply Agreement has expired based on the mutual agreement of Maruho and Dermira, except that Sections 3.3 (with respect to Drug Substance, as defined therein, delivered by Dermira prior to the First Restatement Date) and 7.5 of the Development Supply Agreement shall survive such expiration, and from and after the First Restatement Date, Maruho shall be solely responsible for the procurement and manufacture of [***]and the Product for \u2587\u2587\u2587\u2587\u2587\u2587\u2019s non-clinical and clinical Development. If, following the First Restatement Date, either Party reasonable determines that events or circumstances require the amendment or modification of the terms of any pharmacovigilance agreement between the Parties, the Parties agree to negotiate in good faith with respect to such amendment or modification.", "samples": [{"hash": "gz2881fVo7Q", "uri": "/contracts/gz2881fVo7Q#development-supply-agreement", "label": "Exclusive License Agreement (Journey Medical Corp)", "score": 34.864476386, "published": true}], "hash": "1e422acb397c465afe24500b1423a9fc", "id": 10}], "next_curs": "CmUSX2oVc35sYXdpbnNpZGVyY29udHJhY3RzckELEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IiVkZXZlbG9wbWVudC1zdXBwbHktYWdyZWVtZW50IzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"children": [], "parents": [["manufacture-and-supply-of-the-licensed-product", "Manufacture and Supply of the Licensed Product"], ["manufacturing-and-technology-transfer", "Manufacturing and Technology Transfer"], ["manufacture-and-supply-of-the-product", "Manufacture and Supply of the Product"], ["definitions", "Definitions"], ["license-grant", "License Grant"]], "title": "Development Supply Agreement", "size": 24, "id": "development-supply-agreement", "related": [["supply-agreement", "Supply Agreement", "Supply Agreement"], ["license-agreement", "License Agreement", "License Agreement"], ["supply-agreements", "Supply Agreements", "Supply Agreements"], ["development-agreement", "Development Agreement", "Development Agreement"], ["software-license-agreement", "Software License Agreement", "Software License Agreement"]], "related_snippets": [], "updated": "2025-07-07T12:37:53+00:00", "also_ask": [], "drafting_tip": null, "explanation": "A Development Supply Agreement is a contract that outlines the terms under which one party will develop and supply goods or materials to another party, often in the context of new product development or manufacturing. This agreement typically specifies the scope of development, delivery schedules, quality standards, pricing, and responsibilities of each party throughout the development and supply process. By clearly defining these terms, the agreement helps ensure that both parties understand their obligations and reduces the risk of disputes related to product specifications, timelines, or supply continuity."}, "json": true, "cursor": ""}}