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With respect to each Calendar Year following the Effective Date, Licensee shall deliver to Mount Sinai an annual updated Development Plan in accordance with Section 6.5, which shall set forth in reasonable detail the planned Development activities for such Calendar Year and the subsequent Calendar Year, as well as the anticipated timeline and budget for such activities. Such updated Development Plan shall replace the prior Development Plan and become incorporated into and a part of this Agreement only upon written approval of Mount Sinai of such updated Development Plan. Licensee has not fulfilled its obligations under this Section 3.1 until such approval of Mount Sinai of such updated Development Plan is provided. Licensee will promptly provide additional information as reasonably requested by Mount Sinai.", "hash": "9a678ba0ebf31cabf299f41eda925d3c", "id": 9}, {"snippet_links": [{"key": "the-term", "type": "clause", "offset": [0, 8]}], "size": 16, "samples": [{"hash": "boOy8QHPF5d", "uri": "/contracts/boOy8QHPF5d#development-plan", "label": "License Agreement (Gemini Therapeutics, Inc. /DE)", "score": 33.6680374146, "published": true}, {"hash": "9k1MaVJP2On", "uri": "/contracts/9k1MaVJP2On#development-plan", "label": "License Agreement (CinCor Pharma, Inc.)", "score": 32.9589309692, "published": true}, {"hash": "j9bbB4YgprD", "uri": "/contracts/j9bbB4YgprD#development-plan", "label": "Collaboration and License Agreement (Blueprint Medicines Corp)", "score": 32.5701560974, "published": true}], "snippet": "The term \u201c", "hash": "e6abc5b81feb3c0a954d10eb23e67d9b", "id": 5}, {"snippet_links": [{"key": "execution-of-this-agreement", "type": "clause", "offset": [19, 46]}, {"key": "collaboration-product", "type": "definition", "offset": [53, 74]}, {"key": "development-activities", "type": "clause", "offset": [265, 287]}, {"key": "by-each-party", "type": "clause", "offset": [304, 317]}, {"key": "the-location", "type": "clause", "offset": [387, 399]}, {"key": "budget-and-timelines", "type": "clause", "offset": [411, 431]}, {"key": "completion-of", "type": "definition", "offset": [436, 449]}, {"key": "the-development-plan", "type": "clause", "offset": [527, 547]}, {"key": "product-1", "type": "definition", "offset": [552, 561]}, {"key": "in-accordance-with", "type": "clause", "offset": [571, 589]}, {"key": "plan-set", "type": "clause", "offset": [604, 612]}, {"key": "exhibit-i", "type": "definition", "offset": [622, 631]}, {"key": "subject-to-the", "type": "definition", "offset": [664, 678]}, {"key": "approval-of", "type": "clause", "offset": [710, 721]}, {"key": "signed-by", "type": "definition", "offset": [773, 782]}, {"key": "duly-authorized-representative", "type": "clause", "offset": [785, 815]}, {"key": "for-the-avoidance-of-doubt", "type": "clause", "offset": [881, 907]}, {"key": "neither-party-shall", "type": "clause", "offset": [909, 928]}, {"key": "with-respect-to", "type": "clause", "offset": [949, 964]}, {"key": "the-parties-shall", "type": "clause", "offset": [1099, 1116]}, {"key": "good-faith-efforts", "type": "definition", "offset": [1121, 1139]}, {"key": "from-the-effective-date", "type": "clause", "offset": [1282, 1305]}, {"key": "general-allocation-of-responsibilities", "type": "clause", "offset": [1416, 1454]}, {"key": "without-limiting-the-foregoing", "type": "clause", "offset": [1487, 1517]}, {"key": "modifications-or-additions", "type": "clause", "offset": [1532, 1558]}, {"key": "approved-by", "type": "definition", "offset": [1598, 1609]}, {"key": "prior-to", "type": "definition", "offset": [1614, 1622]}, {"key": "allocated-to", "type": "definition", "offset": [1684, 1696]}, {"key": "terms-and-conditions-of-this-agreement", "type": "clause", "offset": [1751, 1789]}, {"key": "diligence-requirement", "type": "clause", "offset": [1805, 1826]}, {"key": "article-9", "type": "definition", "offset": [1840, 1849]}, {"key": "applicable-development", "type": "definition", "offset": [1856, 1878]}, {"key": "all-applicable-laws", "type": "definition", "offset": [1888, 1907]}], "size": 12, "samples": [{"hash": "14a2XOnzAiO", "uri": "/contracts/14a2XOnzAiO#development-plan", "label": "Joint Development and License Agreement (Pieris Pharmaceuticals, Inc.)", "score": 26.2402458191, "published": true}, {"hash": "2MFbiXrZ3gG", "uri": "/contracts/2MFbiXrZ3gG#development-plan", "label": "Joint Development and License Agreement (Marika Inc.)", "score": 25.9609851837, "published": true}], "snippet": "Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pieris and Stelis BioPharma shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees [***] for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor (each, a \u201cDevelopment Plan\u201d); provided, however, that the Development Plan for Product 1 shall be in accordance with the framework plan set forth in Exhibit I. Each Development Plan shall be subject to the JSC\u2019s approval. Upon the JSC\u2019s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, neither Party shall have any obligation with respect to any activity except as set forth in a Development Plan; provided, however, that unless and until the Parties sign a Development Plan, the Parties shall use good faith efforts to prepare and agree on the Development Plan for Product 1 with respect to activities beyond those referred to in Exhibit I within [***] days from the Effective Date. Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Article 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 9), the applicable Development Plan and all Applicable Laws.", "hash": "a7341e42ee14cd4badc04f8e89d4d92f", "id": 8}, {"snippet_links": [{"key": "authorized-area", "type": "clause", "offset": [36, 51]}, {"key": "approved-development", "type": "definition", "offset": [86, 106]}, {"key": "subsequent-modifications", "type": "clause", "offset": [115, 139]}, {"key": "approved-by", "type": "definition", "offset": [140, 151]}, {"key": "the-lessee", "type": "clause", "offset": [160, 170]}, {"key": "responsible-for", "type": "clause", "offset": [174, 189]}, {"key": "development-and-operations", "type": "clause", "offset": [208, 234]}, {"key": "the-development-plan", "type": "clause", "offset": [289, 309]}, {"key": "in-writing", "type": "definition", "offset": [327, 337]}, {"key": "change-in-use", "type": "definition", "offset": [359, 372]}], "size": 19, "samples": [{"hash": "iHzad3F5D0N", "uri": "/contracts/iHzad3F5D0N#development-plan", "label": "Lease Agreement", "score": 34.3498878479, "published": true}, {"hash": "3h208CAYwjH", "uri": "/contracts/3h208CAYwjH#development-plan", "label": "Lease Agreement", "score": 33.8625679016, "published": true}, {"hash": "iW3rV4xp78q", "uri": "/contracts/iW3rV4xp78q#development-plan", "label": "Lease Agreement", "score": 33.2824707031, "published": true}], "snippet": "Development shall be limited to the authorized area and improvements specified in the approved development plan or subsequent modifications approved by the AO. The Lessee is responsible for accurately siting development and operations within the authorized area. Any proposed revisions to the development plan must be approved in writing by the AO before the change in use or development occurs.", "hash": "fa3473d48ef157670c1f221d8149f3bf", "id": 3}, {"snippet_links": [{"key": "exhibit-a", "type": "definition", "offset": [42, 51]}, {"key": "prepared-by", "type": "clause", "offset": [52, 63]}, {"key": "amendments-and-revisions", "type": "clause", "offset": [198, 222]}, {"key": "this-agreement", "type": "clause", "offset": [321, 335]}, {"key": "by-reference", "type": "clause", "offset": [336, 348]}, {"key": "with-respect-to", "type": "clause", "offset": [432, 447]}, {"key": "the-development-plan", "type": "clause", "offset": [448, 468]}, {"key": "the-developer", "type": "clause", "offset": [470, 483]}, {"key": "upon-request", "type": "definition", "offset": [491, 503]}, {"key": "supplemental-information", "type": "clause", "offset": [531, 555]}, {"key": "in-connection", "type": "clause", "offset": [556, 569]}, {"key": "construction-of", "type": "clause", "offset": [630, 645]}, {"key": "underground-facility", "type": "definition", "offset": [651, 671]}, {"key": "to-the-town", "type": "clause", "offset": [692, 703]}, {"key": "developer-shall", "type": "clause", "offset": [723, 738]}, {"key": "pay-to", "type": "definition", "offset": [857, 863]}, {"key": "per-day", "type": "clause", "offset": [894, 901]}, {"key": "the-drawings", "type": "clause", "offset": [939, 951]}, {"key": "total-amount", "type": "definition", "offset": [975, 987]}, {"key": "required-by", "type": "definition", "offset": [1035, 1046]}, {"key": "paragraph-5", "type": "clause", "offset": [1047, 1058]}, {"key": "failure-to-pay", "type": "definition", "offset": [1063, 1077]}, {"key": "within-thirty", "type": "clause", "offset": [1091, 1104]}, {"key": "act-of-default", "type": "definition", "offset": [1179, 1193]}, {"key": "to-exercise", "type": "clause", "offset": [1213, 1224]}, {"key": "paragraph-11", "type": "clause", "offset": [1251, 1263]}, {"key": "in-the-event-of", "type": "definition", "offset": [1265, 1280]}, {"key": "conflict-or-inconsistency", "type": "clause", "offset": [1285, 1310]}, {"key": "standard-details", "type": "definition", "offset": [1452, 1468]}, {"key": "development-guidelines", "type": "definition", "offset": [1470, 1492]}, {"key": "subdivision-regulations", "type": "clause", "offset": [1524, 1547]}, {"key": "landscape-manual", "type": "definition", "offset": [1549, 1565]}, {"key": "most-favorable", "type": "definition", "offset": [1737, 1751]}, {"key": "dispute-between-the-parties", "type": "clause", "offset": [1788, 1815]}, {"key": "the-determination", "type": "clause", "offset": [1853, 1870]}, {"key": "town-engineer", "type": "definition", "offset": [1921, 1934]}, {"key": "final-and-conclusive", "type": "clause", "offset": [1959, 1979]}, {"key": "provisions-of-the", "type": "clause", "offset": [2048, 2065]}, {"key": "zoning-and-subdivision", "type": "clause", "offset": [2066, 2088]}], "size": 11, "samples": [{"hash": "b0TnlSHEcig", "uri": "/contracts/b0TnlSHEcig#development-plan", "label": "Public Works Agreement", "score": 32.1555213928, "published": true}, {"hash": "l0ADXmhzUnb", "uri": "/contracts/l0ADXmhzUnb#development-plan", "label": "Public Works Agreement", "score": 31.9076461792, "published": true}, {"hash": "lMo6GS2CHXM", "uri": "/contracts/lMo6GS2CHXM#development-plan", "label": "Public Works Agreement", "score": 31.8140068054, "published": true}], "snippet": "Those drawings identified on the attached Exhibit A prepared by \u2587\u2587\u2587\u2587\u2587\u2587 Associates, Inc., together with all details and notes shown thereon, and all specifications referred to therein (including all amendments and revisions to date as well as any amendments and revisions lawfully adopted hereafter) are incorporated into this agreement by reference and are sometimes collectively referred to hereafter as the \u201cDevelopment Plan(s)\u201d. With respect to the Development Plan, the Developer agrees upon request of the Town to furnish any supplemental information in connection therewith. Within ninety (90) days of the completion of the construction of each underground facility and testing thereof to the Town\u2019s satisfaction the Developer shall deliver \u201cas built\u201d drawings with respect thereto to the Town. If not delivered within ninety days the Developer shall pay to the Town a penalty of $100.00 per day for each day beyond said period that the drawings are not delivered, the total amount of the penalty to be a charge against the bond required by paragraph 5 and failure to pay said penalty within thirty (30) days of the date when the drawings are delivered shall constitute an act of default entitling the Town to exercise the remedies set forth in paragraph 11. In the event of any conflict or inconsistency between one part of the Development Plan and any other part of the Development Plan or between said Development Plan and any specifications, standard details, development guidelines of the Town of Mount Airy, the subdivision regulations, landscape manual and ordinances of the Town of Mount Airy, or between any of them and this Agreement, then, in that event, such conflict or inconsistency shall be interpreted in the light most favorable to the Town and in the event of any dispute between the parties concerning such interpretations then the determination with respect to such dispute shall be made by the Town Engineer whose decision shall be final and conclusive upon the parties. Developer shall be bound by all of the applicable provisions of the zoning and subdivision regulations and all ordinances of the Town whether or not mentioned herein.", "hash": "f5f8bc7d0eb1978a8781202ab31d571f", "id": 10}, {"snippet_links": [{"key": "within-thirty", "type": "clause", "offset": [0, 13]}, {"key": "after-the-effective-date", "type": "clause", "offset": [24, 48]}, {"key": "initial-development-plan", "type": "definition", "offset": [79, 103]}, {"key": "the-non", "type": "clause", "offset": [119, 126]}, {"key": "clinical-development-activities", "type": "clause", "offset": [140, 171]}, {"key": "with-respect-to", "type": "clause", "offset": [172, 187]}, {"key": "the-product", "type": "definition", "offset": [188, 199]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [200, 226]}, {"key": "the-parties-shall", "type": "clause", "offset": [276, 293]}, {"key": "by-the-parties", "type": "clause", "offset": [431, 445]}, {"key": "during-the-term", "type": "clause", "offset": [507, 522]}, {"key": "in-this-agreement", "type": "definition", "offset": [561, 578]}, {"key": "agreed-to-by-the", "type": "definition", "offset": [604, 620]}, {"key": "related-parties", "type": "definition", "offset": [646, 661]}, {"key": "sole-authority", "type": "clause", "offset": [673, 687]}, {"key": "control-of", "type": "definition", "offset": [698, 708]}, {"key": "development-of-compounds-and-products", "type": "clause", "offset": [714, 751]}, {"key": "in-the-territory", "type": "clause", "offset": [752, 768]}, {"key": "expenses-of", "type": "clause", "offset": [873, 884]}, {"key": "prior-to", "type": "definition", "offset": [903, 911]}, {"key": "each-calendar-year", "type": "definition", "offset": [925, 943]}, {"key": "related-party", "type": "definition", "offset": [976, 989]}, {"key": "updated-development-plan", "type": "clause", "offset": [1007, 1031]}, {"key": "from-time-to-time", "type": "clause", "offset": [1135, 1152]}, {"key": "sole-discretion", "type": "definition", "offset": [1174, 1189]}, {"key": "annual-updates", "type": "clause", "offset": [1227, 1241]}, {"key": "provide-to", "type": "clause", "offset": [1284, 1294]}, {"key": "in-the-event-of", "type": "definition", "offset": [1335, 1350]}, {"key": "changes-to-the-development-plan", "type": "clause", "offset": [1364, 1395]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [1468, 1497]}, {"key": "modification-to", "type": "clause", "offset": [1507, 1522]}, {"key": "obligations-of", "type": "clause", "offset": [1583, 1597]}, {"key": "require-the", "type": "clause", "offset": [1614, 1625]}, {"key": "approval-of", "type": "clause", "offset": [1640, 1651]}, {"key": "activities-of-the", "type": "clause", "offset": [1720, 1737]}, {"key": "sufficient-detail", "type": "clause", "offset": [1769, 1786]}, {"key": "to-determine", "type": "clause", "offset": [1807, 1819]}, {"key": "compliance-with", "type": "definition", "offset": [1834, 1849]}, {"key": "diligence-obligations", "type": "definition", "offset": [1854, 1875]}, {"key": "phase-of", "type": "clause", "offset": [2035, 2043]}, {"key": "subject-to", "type": "definition", "offset": [2211, 2221]}, {"key": "approval-rights", "type": "definition", "offset": [2234, 2249]}, {"key": "change-to", "type": "definition", "offset": [2354, 2363]}, {"key": "material-adverse-effect-on", "type": "definition", "offset": [2424, 2450]}, {"key": "commercialization-activities", "type": "clause", "offset": [2466, 2494]}, {"key": "by-or-on-behalf-of", "type": "definition", "offset": [2533, 2551]}, {"key": "outside-the-territory", "type": "clause", "offset": [2580, 2601]}, {"key": "in-good-faith", "type": "definition", "offset": [2688, 2701]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [2706, 2741]}, {"key": "clinical-trials", "type": "definition", "offset": [2776, 2791]}, {"key": "pursuant-to-the", "type": "clause", "offset": [2819, 2834]}, {"key": "in-accordance-with", "type": "clause", "offset": [2871, 2889]}, {"key": "all-applicable-laws", "type": "definition", "offset": [2890, 2909]}, {"key": "ich-guidelines", "type": "definition", "offset": [2925, 2939]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [3028, 3051]}, {"key": "confidential-information-of", "type": "clause", "offset": [3108, 3135]}], "size": 14, "samples": [{"hash": "501QBNeT6dS", "uri": "/contracts/501QBNeT6dS#development-plan", "label": "License Agreement", "score": 31.3408622742, "published": true}, {"hash": "2nTlmXWYIwd", "uri": "/contracts/2nTlmXWYIwd#development-plan", "label": "License Agreement (Capstone Therapeutics Corp.)", "score": 29.3449687958, "published": true}], "snippet": "Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the \u201cInitial Development Plan\u201d). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma\u2019s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX\u2019s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for the Compound or Product conducted by or on behalf of LipimetiX or its Affiliates outside the Territory, the Parties shall discuss such concerns and Anji Pharma shall consider such concerns in good faith and use Commercially Reasonable Efforts to address any such concerns. All clinical trials conducted in the Territory pursuant to the Development Plan shall be performed in accordance with all Applicable Laws as well as the ICH guidelines. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. The Development Plan shall be considered Confidential Information of Anji Pharma.", "hash": "549dc396d1380ca21be8b6eb9678d727", "id": 7}, {"snippet_links": [{"key": "initial-development-plan", "type": "definition", "offset": [8, 32]}, {"key": "initial-indications", "type": "clause", "offset": [72, 91]}, {"key": "exhibit-b", "type": "clause", "offset": [114, 123]}, {"key": "as-amended", "type": "definition", "offset": [125, 135]}, {"key": "from-time-to-time", "type": "clause", "offset": [136, 153]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [154, 180]}, {"key": "development-activities", "type": "clause", "offset": [320, 342]}, {"key": "by-each-party", "type": "clause", "offset": [359, 372]}, {"key": "the-relevant", "type": "clause", "offset": [377, 389]}, {"key": "decision-points", "type": "clause", "offset": [421, 436]}, {"key": "development-of-a", "type": "clause", "offset": [449, 465]}, {"key": "in-the-territory", "type": "clause", "offset": [552, 568]}, {"key": "with-respect-to", "type": "clause", "offset": [569, 584]}, {"key": "approval-of", "type": "clause", "offset": [628, 639]}, {"key": "estimated-timeline", "type": "clause", "offset": [681, 699]}, {"key": "performance-of-activities", "type": "clause", "offset": [708, 733]}, {"key": "annual-basis", "type": "clause", "offset": [781, 793]}, {"key": "changes-to-the-development-plan", "type": "clause", "offset": [869, 900]}, {"key": "development-of-products", "type": "clause", "offset": [953, 976]}, {"key": "by-parties", "type": "clause", "offset": [996, 1006]}, {"key": "good-clinical-practices", "type": "definition", "offset": [1019, 1042]}, {"key": "good-laboratory-practices", "type": "definition", "offset": [1055, 1080]}, {"key": "good-laboratory-practice-standards", "type": "clause", "offset": [1115, 1149]}, {"key": "current-good-laboratory-practice", "type": "definition", "offset": [1202, 1234]}, {"key": "the-fda", "type": "clause", "offset": [1272, 1279]}, {"key": "applicable-laws", "type": "clause", "offset": [1331, 1346]}, {"key": "the-design", "type": "clause", "offset": [1484, 1494]}, {"key": "reporting-of", "type": "clause", "offset": [1564, 1576]}, {"key": "clinical-trials", "type": "definition", "offset": [1577, 1592]}, {"key": "requirements-for-registration", "type": "clause", "offset": [1698, 1727]}, {"key": "human-use", "type": "definition", "offset": [1751, 1760]}, {"key": "guidelines-for", "type": "clause", "offset": [1860, 1874]}, {"key": "medicinal-products", "type": "definition", "offset": [1912, 1930]}, {"key": "declaration-of-helsinki", "type": "definition", "offset": [1957, 1980]}, {"key": "further-amendments", "type": "clause", "offset": [2066, 2084]}, {"key": "code-of-federal-regulations", "type": "clause", "offset": [2121, 2148]}, {"key": "protection-of-human-subjects", "type": "clause", "offset": [2169, 2197]}, {"key": "review-boards", "type": "definition", "offset": [2218, 2231]}, {"key": "investigational-new-drug-application", "type": "definition", "offset": [2242, 2278]}, {"key": "each-case", "type": "definition", "offset": [2435, 2444]}, {"key": "provide-for", "type": "clause", "offset": [2451, 2462]}, {"key": "clinical-data", "type": "clause", "offset": [2503, 2516]}, {"key": "the-rights", "type": "clause", "offset": [2576, 2586]}, {"key": "and-confidentiality", "type": "clause", "offset": [2599, 2618]}], "size": 18, "samples": [{"hash": "2ez19I7ilry", "uri": "/contracts/2ez19I7ilry#development-plan", "label": "Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD)", "score": 30.4072551727, "published": true}, {"hash": "fIgWtHiCQWi", "uri": "/contracts/fIgWtHiCQWi#development-plan", "label": "Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD)", "score": 30.3305950165, "published": true}, {"hash": "10sshq3DEr7", "uri": "/contracts/10sshq3DEr7#development-plan", "label": "Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD)", "score": 26.7878170013, "published": true}], "snippet": "(a) The initial Development plan for the Development of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the \u201cDevelopment Plan\u201d). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimates.\n(b) On no less than an annual basis, the JSC shall review the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes.\n(c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (\u201cGCP\u201d) and good laboratory practices (\u201cGLP\u201d). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (\u201cICH\u201d) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.", "hash": "047142ac1e03c3fe333347ea4eda2f3b", "id": 4}, {"snippet_links": [{"key": "not-commence", "type": "clause", "offset": [34, 46]}, {"key": "exploitation-of-the-unit-reservoirs", "type": "clause", "offset": [90, 125]}, {"key": "submitted-by", "type": "clause", "offset": [142, 154]}, {"key": "unit-operator", "type": "definition", "offset": [159, 172]}, {"key": "in-accordance-with", "type": "clause", "offset": [215, 233]}, {"key": "approved-by", "type": "definition", "offset": [272, 283]}, {"key": "regulatory-authorities", "type": "clause", "offset": [288, 310]}, {"key": "copies-of-the", "type": "clause", "offset": [343, 356]}, {"key": "for-approval", "type": "definition", "offset": [404, 416]}, {"key": "the-commission", "type": "clause", "offset": [422, 436]}, {"key": "make-recommendations", "type": "clause", "offset": [453, 473]}, {"key": "with-regard-to", "type": "clause", "offset": [504, 518]}, {"key": "the-project", "type": "clause", "offset": [617, 628]}, {"key": "commercially-viable", "type": "definition", "offset": [632, 651]}, {"key": "the-contractor", "type": "definition", "offset": [657, 671]}, {"key": "resources-needed", "type": "clause", "offset": [713, 729]}, {"key": "consistent-with", "type": "definition", "offset": [889, 904]}, {"key": "good-oilfield-practice", "type": "definition", "offset": [905, 927]}, {"key": "could-reasonably-be-expected-to", "type": "definition", "offset": [960, 991]}, {"key": "specified-period", "type": "clause", "offset": [1047, 1063]}, {"key": "entered-into", "type": "clause", "offset": [1100, 1112]}, {"key": "contracts-for", "type": "clause", "offset": [1113, 1126]}, {"key": "sale-of", "type": "clause", "offset": [1131, 1138]}, {"key": "the-criteria", "type": "clause", "offset": [1337, 1349]}, {"key": "unit-area", "type": "definition", "offset": [1492, 1501]}, {"key": "at-any-time", "type": "clause", "offset": [1578, 1589]}, {"key": "to-submit", "type": "definition", "offset": [1670, 1679]}, {"key": "up-to-date", "type": "definition", "offset": [1700, 1710]}, {"key": "amendments-or-additions", "type": "clause", "offset": [1756, 1779]}, {"key": "require-the", "type": "clause", "offset": [1804, 1815]}, {"key": "approval-of", "type": "clause", "offset": [1822, 1833]}, {"key": "regulatory-authority", "type": "definition", "offset": [1918, 1938]}, {"key": "amendment-to-the-development-plan", "type": "clause", "offset": [1971, 2004]}, {"key": "with-a-view-to", "type": "definition", "offset": [2112, 2126]}, {"key": "reaching-agreement", "type": "clause", "offset": [2127, 2145]}, {"key": "sunrise-joint-venturers", "type": "definition", "offset": [2196, 2219]}, {"key": "unit-installation", "type": "definition", "offset": [2264, 2281]}, {"key": "approved-development", "type": "definition", "offset": [2526, 2546]}, {"key": "no-action", "type": "clause", "offset": [2553, 2562]}], "size": 14, "samples": [{"hash": "9dwEkxx5pS6", "uri": "/contracts/9dwEkxx5pS6#development-plan", "label": "Agreement Between the Government of Australia and the Government of the Democratic Republic of Timor Leste Relating to the Unitisation of the Sunrise and Troubadour Fields", "score": 24.6194381714, "published": true}, {"hash": "jlfKOCOzmPI", "uri": "/contracts/jlfKOCOzmPI#development-plan", "label": "Unitisation Agreement", "score": 21.0, "published": true}, {"hash": "hBF3ViafaCa", "uri": "/contracts/hBF3ViafaCa#development-plan", "label": "Joint Petroleum Development Agreement", "score": 21.0, "published": true}], "snippet": "(1) Production of petroleum shall not commence until a Development Plan for the effective exploitation of the Unit Reservoirs, which has been submitted by the Unit Operator and contains a programme and plans agreed in accordance with Joint Venturers\u2019 Agreements, has been approved by the Regulatory Authorities. The Unit Operator shall submit copies of the Development Plan to the Regulatory Authorities for approval.\n(2) The Commission may review, and make recommendations to the Regulatory Authorities with regard to, a Development Plan.\n(3) The Regulatory Authorities shall approve the Development Plan where:\n(a) the project is commercially viable;\n(b) the contractor or licensee possesses the competence and resources needed to exploit the reservoir to the best commercial advantage;\n(c) the contractor or licensee is seeking to exploit the reservoir to the best commercial advantage consistent with good oilfield practice;\n(d) the contractor or licensee could reasonably be expected to carry out the exploitation of the reservoir during the specified period;\n(e) the contractor or licensee has entered into contracts for the sale of gas from the project which are consistent with arm\u2019s length transactions.\n(4) The Regulatory Authorities shall specify their reasons for not approving a Development Plan including identification of the criteria in paragraph (2) that the contractor or licensee has failed to meet.\n(5) The Regulatory Authorities shall ensure that the exploitation of the Unit Area shall be in accordance with the Development Plan.\n(6) The Unit Operator may at any time submit, and if at any time the Regulatory Authorities so decide may be required to submit, proposals to bring up to date or otherwise amend the Development Plan. All amendments or additions to the Development Plan require the prior approval of the Regulatory Authorities.\n(7) Where the Unit Operator has been notified by either Regulatory Authority that the Development Plan or an amendment to the Development Plan has not been approved, the Regulatory Authorities shall consult with each other and with the Unit Operator with a view to reaching agreement.\n(8) The Regulatory Authorities shall require the Sunrise Joint Venturers not to change the status or function of any Unit Installation in the Unit Area in any way except in accordance with an amendment to the Development Plan in accordance with paragraph (2).\n(9) Where a Sunrise Joint Venturer has entered into contracts for the sale of gas from the project that are part of an approved Development Plan, no action may be taken by the Regulatory Authorities to withhold the supply of that gas.", "hash": "df409ad59d7681704a5e56ef47dead25", "id": 6}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhlkZXZlbG9wbWVudC1wbGFuIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"children": [["initial-development-plan", "Initial Development Plan"], ["general", "General"], ["development-plan", "Development Plan"], ["amendments", "Amendments"], ["", ""]], "parents": [["development", "Development"], ["definitions", "Definitions"], ["development-and-commercialization", "Development and Commercialization"], ["diligence", "Diligence"], ["product-development", "Product Development"]], "size": 2098, "title": "Development Plan", "id": "development-plan", "related": [["development-plans", "Development Plans", "<strong>Development Plans</strong>"], ["commercialization-plan", "Commercialization Plan", "Commercialization Plan"], ["development-program", "Development Program", "Development Program"], ["research-plan", "Research Plan", "Research Plan"], ["development-activities", "Development Activities", "Development Activities"]], "related_snippets": [], "updated": "2026-07-10T04:32:06+00:00", "also_ask": ["What are the essential elements that must be included in a robust Development Plan clause?", "How can parties negotiate milestones and remedies for delays to maximize leverage?", "What are the most common pitfalls or ambiguities that lead to disputes over Development Plan obligations?", "How do courts typically interpret and enforce Development Plan clauses in the event of non-performance?", "How does this Development Plan clause compare to industry standards or similar agreements in other jurisdictions?"], "drafting_tip": "Specify deliverables and timelines to ensure accountability; require approval procedures to maintain quality control; define modification processes to manage changes efficiently.", "explanation": "A Development Plan clause outlines the specific steps, milestones, and timelines that parties must follow to complete a project or achieve certain deliverables. It typically details the responsibilities of each party, sets deadlines for key phases, and may include requirements for progress reports or meetings to monitor advancement. By clearly defining expectations and schedules, this clause helps ensure that the project proceeds in an organized manner and reduces the risk of misunderstandings or delays."}, "json": true, "cursor": ""}}