{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "subject-to-sections", "type": "clause", "offset": [0, 19]}, {"key": "responsible-for", "type": "clause", "offset": [59, 74]}, {"key": "the-development", "type": "clause", "offset": [75, 90]}, {"key": "improved-products", "type": "clause", "offset": [139, 156]}, {"key": "be-responsible", "type": "clause", "offset": [174, 188]}, {"key": "costs-incurred", "type": "definition", "offset": [197, 211]}, {"key": "in-connection-with", "type": "clause", "offset": [212, 230]}, {"key": "fibroblast-program", "type": "definition", "offset": [235, 253]}, {"key": "costs-of", "type": "definition", "offset": [319, 327]}, {"key": "manufacturing-capabilities", "type": "clause", "offset": [341, 367]}, {"key": "manufacturing-obligation", "type": "clause", "offset": [413, 437]}, {"key": "section-46", "type": "clause", "offset": [444, 455]}, {"key": "allocable-portion", "type": "definition", "offset": [505, 522]}, {"key": "depreciation-and-amortization", "type": "clause", "offset": [546, 575]}, {"key": "calculating-the", "type": "clause", "offset": [582, 597]}, {"key": "cost-of-manufacturing", "type": "definition", "offset": [611, 632]}, {"key": "fibrocell-product", "type": "definition", "offset": [635, 652]}, {"key": "to-the-extent", "type": "clause", "offset": [654, 667]}, {"key": "us-gaap", "type": "clause", "offset": [732, 739]}, {"key": "the-majority", "type": "clause", "offset": [766, 778]}, {"key": "basic-research", "type": "definition", "offset": [877, 891]}, {"key": "with-respect-to", "type": "clause", "offset": [892, 907]}, {"key": "intrexon-channel-technology", "type": "definition", "offset": [912, 939]}, {"key": "intrexon-materials", "type": "definition", "offset": [944, 962]}, {"key": "for-clarity", "type": "clause", "offset": [998, 1009]}, {"key": "section-47", "type": "clause", "offset": [1043, 1054]}, {"key": "requested-by", "type": "clause", "offset": [1067, 1079]}, {"key": "development-of-a", "type": "clause", "offset": [1096, 1112]}, {"key": "research-costs", "type": "clause", "offset": [1161, 1175]}, {"key": "maintenance-of", "type": "clause", "offset": [1265, 1279]}, {"key": "intrexon-patents", "type": "definition", "offset": [1280, 1296]}, {"key": "active-pharmaceutical-ingredients", "type": "definition", "offset": [1409, 1442]}, {"key": "clinical-trials", "type": "clause", "offset": [1447, 1462]}, {"key": "pursuant-to-section", "type": "definition", "offset": [1518, 1537]}, {"key": "third-party-contractors", "type": "definition", "offset": [1641, 1664]}], "snippet": "Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon\u2019s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon\u2019s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon\u2019s consent).", "samples": [{"hash": "FqP4X806I2", "uri": "/contracts/FqP4X806I2#development-and-commercialization", "label": "Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.)", "score": 32.5373039246, "published": true}, {"hash": "21YulHc3wiS", "uri": "/contracts/21YulHc3wiS#development-and-commercialization", "label": "Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.)", "score": 32.4031486511, "published": true}, {"hash": "daEf93CUbjV", "uri": "/contracts/daEf93CUbjV#development-and-commercialization", "label": 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{"key": "tests-and-trials", "type": "clause", "offset": [1504, 1520]}, {"key": "actions-taken", "type": "clause", "offset": [1545, 1558]}, {"key": "pursuant-to-the", "type": "definition", "offset": [1574, 1589]}, {"key": "summary-of-the", "type": "clause", "offset": [1614, 1628]}, {"key": "related-work", "type": "definition", "offset": [1663, 1675]}, {"key": "the-report", "type": "clause", "offset": [1781, 1791]}, {"key": "marketing-and-sales", "type": "clause", "offset": [1826, 1845]}, {"key": "the-testing", "type": "definition", "offset": [1942, 1953]}, {"key": "commercialization-of-products", "type": "clause", "offset": [1980, 2009]}, {"key": "subject-to", "type": "definition", "offset": [2067, 2077]}, {"key": "sole-discretion", "type": "clause", "offset": [2082, 2097]}, {"key": "development-and-registration", "type": "clause", "offset": [2116, 2144]}, {"key": "commercially-reasonable", "type": "clause", "offset": [2152, 2175]}, {"key": "licensed-technology", "type": "clause", "offset": [2203, 2222]}, {"key": "in-the-field", "type": "clause", "offset": [2223, 2235]}, {"key": "the-products", "type": "clause", "offset": [2326, 2338]}, {"key": "time-frame", "type": "clause", "offset": [2359, 2369]}, {"key": "caused-by", "type": "clause", "offset": [2392, 2401]}, {"key": "the-requirements", "type": "clause", "offset": [2406, 2422]}, {"key": "governmental-authority", "type": "definition", "offset": [2448, 2470]}, {"key": "force-majeure", "type": "definition", "offset": [2477, 2490]}, {"key": "section-179", "type": "clause", "offset": [2510, 2522]}, {"key": "have-agreed", "type": "clause", "offset": [2570, 2581]}, {"key": "in-writing", "type": "clause", "offset": [2582, 2592]}, {"key": "to-amend", "type": "definition", "offset": [2593, 2601]}, {"key": "notify-the", "type": "clause", "offset": [2637, 2647]}, {"key": "company-in", "type": "clause", "offset": [2648, 2658]}, {"key": "of-the-company", "type": "clause", "offset": [2667, 2681]}, {"key": "failure-to-meet", "type": "clause", "offset": [2684, 2699]}, {"key": "obligations-of", "type": "clause", "offset": [2704, 2718]}, {"key": "working-days", "type": "definition", "offset": [2768, 2780]}, {"key": "failure-to-cure", "type": "definition", "offset": [2830, 2845]}, {"key": "reasonable-satisfaction", "type": "definition", "offset": [2901, 2924]}, {"key": "material-breach-of-this-agreement", "type": "clause", "offset": [2936, 2969]}, {"key": "termination-under", "type": "clause", "offset": [3001, 3018]}, {"key": "section-152", "type": "clause", "offset": [3019, 3031]}, {"key": "acting-in-good-faith", "type": "clause", "offset": [3078, 3098]}, {"key": "time-line", "type": "clause", "offset": [3163, 3172]}, {"key": "all-applicable-laws-and-regulations", "type": "definition", "offset": [3336, 3371]}, {"key": "receipt-of", "type": "clause", "offset": [3395, 3405]}, {"key": "approvals-and-consents", "type": "clause", "offset": [3410, 3432]}, {"key": "necessary-for", "type": "definition", "offset": [3433, 3446]}, {"key": "the-performance", "type": "clause", "offset": [3447, 3462]}, {"key": "the-company-agrees-to-provide", "type": "clause", "offset": [3498, 3527]}, {"key": "the-university", "type": "definition", "offset": [3542, 3556]}, {"key": "no-consideration", "type": "clause", "offset": [3562, 3578]}, {"key": "number-of-units", "type": "definition", "offset": [3593, 3608]}, {"key": "research-purposes", "type": "definition", "offset": [3689, 3706]}], "snippet": "5.1. The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plan approved by Yissum, a copy of which is attached to this Agreement as Appendix B. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above. In case of a need to modify dates of the achievement of the development milestones set forth in the Development Plan (the \u201cDevelopment Milestones\u201d) a prior notice regarding the modification will be sent to Yissum by the Company. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.\n5.2. The Company shall (i) provide Yissum with periodic written reports (\u201cDevelopment Reports\u201d) not less than once per twelve (12) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Y\u2587\u2587\u2587\u2587\u2587 informed on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum\u2019s request, from time to time, provide Yissum with further information relating to the Company\u2019s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the twelve (12) month\u2019 period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the twelve (12) month\u2019 period prior to the report; (c) the Company\u2019s plans in respect of the testing, undertaking of trials or commercialization of Products for the following twelve (12) months .\n5.3. The Company, subject to its sole discretion, shall pursue the development and registration of all commercially reasonable indications or uses of the Licensed Technology in the Field.\n5.4. If the Company shall not meet the Development Milestones or shall not commercialize the Products within a reasonable time frame, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company\u2019s failure to meet its obligations of diligence and shall allow the Company sixty (60) working days to cure such failure of diligence. The Company\u2019s failure to cure within such sixty (60) working days period to Yissum\u2019s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below. Despite the above, if the Company\u2019s is acting in good faith and in a diligent manner to meet the Development Milestone, the time line to reach the Development Milestone will be automatically extended by six (6) month.\n5.5. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.\n5.6. The Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, for academic research purposes only.", "samples": [{"hash": "9hOeGV5TUz", "uri": "/contracts/9hOeGV5TUz#development-and-commercialization", "label": "Research and License Agreement (INNOCAN PHARMA Corp)", "score": 37.2026023865, "published": true}, {"hash": "gWzwrrUjQnG", "uri": "/contracts/gWzwrrUjQnG#development-and-commercialization", "label": "Research and License Agreement (INNOCAN PHARMA Corp)", "score": 36.5893211365, "published": true}, {"hash": "6B9XRRxpsDr", "uri": "/contracts/6B9XRRxpsDr#development-and-commercialization", "label": "Research and License Agreement (INNOCAN PHARMA Corp)", "score": 36.5564689636, "published": true}], "size": 14, "hash": "edc8f608fc9a1e600639011d901c800a", "id": 3}, {"snippet_links": [{"key": "reasonable-diligence", "type": "definition", "offset": [47, 67]}, {"key": "licensed-products", "type": "definition", "offset": [85, 102]}, {"key": "not-limited", "type": "clause", "offset": [118, 129]}, {"key": "the-performance", "type": "clause", "offset": [134, 149]}, {"key": "trials-and-studies", "type": "clause", "offset": [225, 243]}, {"key": "other-activities", "type": "definition", "offset": [252, 268]}, {"key": "in-order-to", "type": "clause", "offset": [279, 290]}, {"key": "approval-of", "type": "definition", "offset": [302, 313]}, {"key": "the-fda", "type": "clause", "offset": [314, 321]}, {"key": "the-production", "type": "clause", "offset": [326, 340]}, {"key": "sale-of-the", "type": "clause", "offset": [350, 361]}, {"key": "the-development-plan", "type": "clause", "offset": [401, 421]}, {"key": "appendix-iii", "type": "definition", "offset": [441, 453]}, {"key": "integral-part", "type": "clause", "offset": [470, 483]}, {"key": "to-exercise", "type": "clause", "offset": [579, 590]}, {"key": "due-diligence", "type": "definition", "offset": [591, 604]}, {"key": "to-employ", "type": "clause", "offset": [609, 618]}, {"key": "health-authorities", "type": "definition", "offset": [688, 706]}, {"key": "other-countries", "type": "clause", "offset": [781, 796]}, {"key": "the-world", "type": "definition", "offset": [800, 809]}, {"key": "provided-that", "type": "clause", "offset": [892, 905]}, {"key": "applicable-laws", "type": "clause", "offset": [906, 921]}, {"key": "rules-and-regulations", "type": "definition", "offset": [923, 944]}, {"key": "in-accordance-with", "type": "definition", "offset": [1080, 1098]}, {"key": "fda-good-laboratory-practices", "type": "definition", "offset": [1099, 1128]}, {"key": "the-relevant", "type": "clause", "offset": [1159, 1171]}, {"key": "good-manufacturing-practice", "type": "clause", "offset": [1457, 1484]}, {"key": "a-facility", "type": "definition", "offset": [1507, 1517]}, {"key": "certified-by", "type": "clause", "offset": [1533, 1545]}, {"key": "complying-with", "type": "clause", "offset": [1557, 1571]}, {"key": "regular-commercial-production", "type": "definition", "offset": [1684, 1713]}, {"key": "in-good-faith", "type": "definition", "offset": [1754, 1767]}, {"key": "annual-reports", "type": "definition", "offset": [1935, 1949]}, {"key": "by-corporation", "type": "clause", "offset": [1991, 2005]}, {"key": "to-develop", "type": "definition", "offset": [2006, 2016]}, {"key": "days-after", "type": "definition", "offset": [2103, 2113]}, {"key": "duration-of-this-agreement", "type": "clause", "offset": [2137, 2163]}, {"key": "time-frame", "type": "clause", "offset": [2252, 2262]}, {"key": "regulatory-agencies", "type": "definition", "offset": [2314, 2333]}, {"key": "to-amend", "type": "definition", "offset": [2385, 2393]}, {"key": "unforeseen-circumstances", "type": "definition", "offset": [2426, 2450]}, {"key": "in-writing", "type": "clause", "offset": [2481, 2491]}, {"key": "failure-to-commercialize", "type": "clause", "offset": [2509, 2533]}, {"key": "failure-to-cure", "type": "definition", "offset": [2630, 2645]}, {"key": "to-nyu", "type": "definition", "offset": [2657, 2663]}, {"key": "reasonable-satisfaction", "type": "definition", "offset": [2666, 2689]}, {"key": "day-period", "type": "definition", "offset": [2705, 2715]}, {"key": "material-breach-of-this-agreement", "type": "clause", "offset": [2727, 2760]}], "snippet": "8.01. CORPORATION undertakes to use continuous reasonable diligence to make and sell Licensed Products, including but not limited to, the performance of all efficacy, pharmaceutical, safety, toxicological and clinical tests, trials and studies and all other activities necessary in order to obtain the approval of the FDA for the production, use and sale of the Licensed Products, all as set forth in the Development Plan (annexed hereto as Appendix III and which is an integral part of this Agreement) and within all timetables set forth therein. CORPORATION further undertakes to exercise due diligence and to employ its reasonable diligence to obtain, the appropriate approvals of the health authorities for the production, use and sale of the Licensed Products, in each of the other countries of the world in which CORPORATION intend to produce, use, and/or sell Licensed Products.\n8.02. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products shall be produced in accordance with FDA Good Manufacturing Practice (\u201cGMP\u201d) procedures in a facility which has been certified by the FDA as complying with GMP, provided that applicable laws, rules and regulations so require.\n8.03. CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed Products in good faith in accordance with the Development Plan and to continue diligently thereafter to commercialize the Licensed Products.\n8.04. CORPORATION shall provide NYU with written annual reports on all activities and actions undertaken by CORPORATION to develop and commercialize the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for the duration of this Agreement.\n8.05. If CORPORATION shall not commercialize the Licensed Products within a reasonable time frame, unless such delay is necessitated by FDA or other regulatory agencies or unless NYU and CORPORATION have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU shall notify CORPORATION in writing of CORPORATION\u2019s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION\u2019s failure to cure such delay to NYU\u2019s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.", "samples": [{"hash": "UlTzDGagtN", "uri": "/contracts/UlTzDGagtN#development-and-commercialization", "label": "License Agreement (Bionano Genomics, Inc.)", "score": 35.5982208252, "published": true}, {"hash": "kvwQ7mlUMBE", "uri": "/contracts/kvwQ7mlUMBE#development-and-commercialization", "label": "License Agreement (BioNano Genomics, Inc)", "score": 29.4873371124, "published": true}, {"hash": "2soT7c4E8wt", "uri": "/contracts/2soT7c4E8wt#development-and-commercialization", "label": "License Agreement (BioNano Genomics, Inc)", "score": 29.3641338348, "published": true}], "size": 33, "hash": "075f425e1e511462190b942788a5087e", "id": 2}, {"snippet_links": [{"key": "best-efforts", "type": "definition", "offset": [60, 72]}, {"key": "manufacturing-and-marketing", "type": "clause", "offset": [115, 142]}, {"key": "to-develop", "type": 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"period-of-force-majeure", "type": "clause", "offset": [5200, 5223]}, {"key": "have-agreed", "type": "clause", "offset": [5272, 5283]}, {"key": "in-writing", "type": "clause", "offset": [5284, 5294]}, {"key": "to-amend", "type": "definition", "offset": [5295, 5303]}, {"key": "the-relevant", "type": "clause", "offset": [5410, 5422]}, {"key": "material-breach-of-this-agreement", "type": "clause", "offset": [5454, 5487]}, {"key": "termination-under", "type": "clause", "offset": [5518, 5535]}, {"key": "section-162", "type": "clause", "offset": [5536, 5548]}, {"key": "all-applicable-laws-and-regulations", "type": "definition", "offset": [5647, 5682]}, {"key": "receipt-of", "type": "clause", "offset": [5706, 5716]}, {"key": "approvals-and-consents", "type": "clause", "offset": [5721, 5743]}, {"key": "necessary-for", "type": "definition", "offset": [5744, 5757]}, {"key": "the-company-agrees-to-provide", "type": "clause", "offset": [5809, 5838]}, {"key": "the-university", "type": "definition", "offset": [5853, 5867]}, {"key": "no-consideration", "type": "clause", "offset": [5873, 5889]}, {"key": "research-purposes", "type": "definition", "offset": [5997, 6014]}], "snippet": "6.1. The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan (with milestones, timetable and budgeting), for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the \"Development Plan\") a copy of which, that meets Yissum\u2019s reasonable approval, shall be finalized by the Company and attached to this Agreement as Appendix D within 120 (one hundred twenty) days from the end of the Research Program that is described in Appendix C of this Agreement and contemplated to be completed within 4 (four) months. The parties agree that the Development Plan will not cover REPEL-CV Products given the funding, development and commercialization by the Company of REPEL-CV Products. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum\u2019s prior written approval, such approval not to be unreasonably delayed or denied, but without derogating from the dates of the achievement of the significant milestones set forth in the Development Plan. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.\n6.2. The parties shall establish a steering committee (the \u201cCommittee\u201d) to oversee the exercise of the License. Each party shall be entitled to designate two representatives to the Committee (the \u201cRepresentatives\u201d), which shall meet at least twice per calendar year. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) provide Yissum with periodic written reports (\u201cDevelopment Reports\u201d) not less than once per every six (6) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's request, from time to time, provide Yissum with further information relating to the Company\u2019s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sub-Licensee during the six month period prior to the report, (ii) the Company\u2019s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 (twelve) months; and (iii) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected or actual completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason for that and shall prepare a modified Development Plan for Yissum\u2019s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder.\n6.3. The Company shall use reasonable commercial efforts to pursue the development and registration of all commercially reasonable indications or uses of the Licensed Technology in the Field.\n6.4. Upon completion of the development of any Product, the Company undertakes to use commercially reasonable efforts necessary to maximize Net Sales of such Product on a regular and consistent basis.\n6.5. The Development Plan shall contain certain milestones designated therein as essential milestones (\u201cEssential Milestone/s\u201d). Failure to meet an Essential Milestone by the date set out in the Development Plan for achieving such Essential Milestone (or any modified date pursuant to section 6.1 above or this section 6.5 below), shall entitle Yissum to termination rights in accordance with section 16 below. The Company shall be entitled to extend the period for meeting an Essential Milestone (\u201cMilestone Extension\u201d) in accordance with the following:\na. The Company shall be entitled to a Milestone Extension of six months for each Essential Milestone\nb. The Company shall be entitled to a Milestone Extension for the period of force majeure and any period for which the Company and Yissum have agreed in writing to amend the Development Plan. The Company's failure to meet the date set for an Essential Milestone together with the relevant Milestone Extension shall be a material breach of this Agreement entitling Yissum to immediate termination under section 16.2 of this Agreement.\n6.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.\n6.7. The Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number units of any Product developed and/or manufactured under this Agreement, for academic research purposes only.", "samples": [{"hash": "lwC7bV1sOnE", "uri": "/contracts/lwC7bV1sOnE#development-and-commercialization", "label": "Research and License Agreement (Pathfinder Cell Therapy, Inc.)", "score": 23.2423000336, "published": true}], "size": 7, "hash": "8f3c36cd32f29181840b7bb16ae6497d", "id": 9}, {"snippet_links": [{"key": "signature-of", "type": "clause", "offset": [48, 60]}, {"key": "the-company-shall", "type": "clause", "offset": [77, 94]}, {"key": "submit-to", "type": "definition", "offset": [95, 104]}, {"key": "written-approval", "type": "definition", "offset": [119, 135]}, {"key": "development-of-products", "type": "clause", "offset": [201, 224]}, {"key": "approved-by", "type": "definition", "offset": [255, 266]}, {"key": "initial-development-program", "type": "definition", 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{"key": "pursuant-to-the", "type": "definition", "offset": [1850, 1865]}, {"key": "other-development", "type": "clause", "offset": [1901, 1918]}, {"key": "marketing-and-sales", "type": "clause", "offset": [2014, 2033]}, {"key": "in-respect-of", "type": "clause", "offset": [2105, 2118]}, {"key": "the-testing", "type": "definition", "offset": [2119, 2130]}, {"key": "sales-and-marketing-efforts", "type": "clause", "offset": [2249, 2276]}, {"key": "following-the-first-commercial-sale", "type": "clause", "offset": [2277, 2312]}, {"key": "to-provide", "type": "clause", "offset": [2694, 2704]}, {"key": "additional-data", "type": "clause", "offset": [2730, 2745]}, {"key": "company-hereunder", "type": "clause", "offset": [2800, 2817]}, {"key": "removal-of", "type": "definition", "offset": [2832, 2842]}, {"key": "remaining-provisions", "type": "definition", "offset": [2878, 2898]}, {"key": "this-clause", "type": "clause", "offset": [2902, 2913]}, {"key": "nothing-contained-in-this-agreement", "type": "clause", "offset": [2941, 2976]}, {"key": "warranty-by-the-company", "type": "clause", "offset": [3001, 3024]}, {"key": "other-results", "type": "definition", "offset": [3129, 3142]}, {"key": "and-the-company", "type": "clause", "offset": [3143, 3158]}, {"key": "no-warranties", "type": "clause", "offset": [3165, 3178]}, {"key": "results-to-be-achieved", "type": "clause", "offset": [3200, 3222]}, {"key": "no-representation", "type": "clause", "offset": [3322, 3339]}, {"key": "the-obligations-of-the-company", "type": "clause", "offset": [3464, 3494]}, {"key": "in-the-event", "type": "clause", "offset": [3566, 3578]}, {"key": "to-develop", "type": "definition", "offset": [3607, 3617]}, {"key": "in-addition-to", "type": "clause", "offset": [3648, 3662]}, {"key": "additional-products", "type": "definition", "offset": [3858, 3877]}, {"key": "the-provisions-of-this", "type": "clause", "offset": [3882, 3904]}, {"key": "with-respect-to", "type": "clause", "offset": [3931, 3946]}, {"key": "development-and-commercialisation", "type": "clause", "offset": [3991, 4024]}, {"key": "mutatis-mutandis", "type": "clause", "offset": [4054, 4070]}, {"key": "the-company-agrees-to", "type": "clause", "offset": [4077, 4098]}, {"key": "no-consideration", "type": "clause", "offset": [4109, 4125]}, {"key": "the-institute", "type": "definition", "offset": [4139, 4152]}, {"key": "one-unit", "type": "definition", "offset": [4153, 4161]}, {"key": "research-purposes", "type": "definition", "offset": [4242, 4259]}, {"key": "all-products", "type": "clause", "offset": [4335, 4347]}, {"key": "applicable-to", "type": "definition", "offset": [4441, 4454]}], "snippet": "8.1. Within 18 (eighteen) months of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, \u201cthe Initial Development Program\u201d). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company\u2019s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1\n8.2. The Company undertakes, at its own expense, to take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein.\n8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on December 31 of each calendar year with written progress reports (\u201cProgress Reports\u201d) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 12 (twelve) months; and (iii) the Company\u2019s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda\u2019s review subject to and without derogating from the milestones set in 13.2 below. The Company shall also make reasonable efforts to provide Yeda with any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.\n8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims or any other results and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. Furthermore, the Company makes no representation to the effect that the commercialization of the Product(s), or any part thereof, will succeed.\n8.5. Without derogating from the obligations of the Company pursuant to this clause 8 or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a further Development Program in respect of such additional Products and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis.\n8.6. The Company agrees to lend (for no consideration) Yeda and/or the Institute one unit of the Product developed and/or manufactured under this Agreement, for academic research purposes only.\n8.7. The Company shall \u2587\u2587\u2587\u2587, and cause all its Sublicensees to \u2587\u2587\u2587\u2587, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.", "samples": [{"hash": "1p1UOm3Uz88", "uri": "/contracts/1p1UOm3Uz88#development-and-commercialization", "label": "Research and License Agreement (Brainsway Ltd.)", "score": 28.0349082947, "published": true}, {"hash": "iI5GVXnoCtL", "uri": "/contracts/iI5GVXnoCtL#development-and-commercialization", "label": "Research and License Agreement (Brainsway Ltd.)", "score": 27.873374939, "published": true}], "size": 9, "hash": "3125df3783abaddb78287eaf891441a5", "id": 6}, {"snippet_links": [{"key": "for-development", "type": "clause", "offset": [35, 50]}, {"key": "all-products", "type": "clause", "offset": [76, 88]}, {"key": "this-agreement", "type": "clause", "offset": [95, 109]}, {"key": "obligation-to-consult", "type": "clause", "offset": [129, 150]}, {"key": "commercialization-activities", "type": "definition", "offset": [195, 223]}], "snippet": "Pieris shall be solely responsible for development and commercialization of all Products under this Agreement, and shall have no obligation to consult with Enumeral regarding such development or commercialization activities.", "samples": [{"hash": "iMMsc6wdhOd", "uri": "/contracts/iMMsc6wdhOd#development-and-commercialization", "label": "License and Transfer Agreement (Enumeral Biomedical Holdings, Inc.)", "score": 27.6119098663, "published": true}, {"hash": "1TRgTtaQKW4", "uri": "/contracts/1TRgTtaQKW4#development-and-commercialization", "label": "License and Transfer Agreement (Pieris Pharmaceuticals, Inc.)", "score": 27.6091709137, "published": true}, {"hash": "85LuTMfIpff", "uri": "/contracts/85LuTMfIpff#development-and-commercialization", "label": "License and Transfer Agreement (Pieris Pharmaceuticals, Inc.)", "score": 27.5489387512, "published": true}], "size": 6, "hash": "8ecc72f6ada55ea5b53d7dd3a882a37b", "id": 10}, {"snippet_links": [{"key": "reasonable-efforts", "type": "definition", "offset": [16, 34]}, {"key": "consistent-with-the", "type": "clause", "offset": [70, 89]}, {"key": "by-merck", "type": "clause", "offset": [114, 122]}, {"key": "commercialization-and-marketing", "type": "clause", "offset": [139, 170]}, {"key": "pharmaceutical-products", "type": "clause", "offset": [192, 215]}, {"key": "to-develop", "type": "definition", "offset": [237, 247]}, {"key": "licensed-product", "type": "clause", "offset": [268, 284]}, {"key": "reasonable-basis", "type": "definition", "offset": [303, 319]}, {"key": "in-the-territory", "type": "clause", "offset": [338, 354]}, {"key": "commercially-viable", "type": "definition", "offset": [386, 405]}], "snippet": "Merck shall use reasonable efforts, --------------------------------- consistent with the usual practice followed by Merck in pursuing the commercialization and marketing of its other similar pharmaceutical products, at its own expense, to develop and commercialize a Licensed Product on a commercially reasonable basis in such countries in the Territory where in Merck's opinion it is commercially viable to do so.", "samples": [{"hash": "b2MZ1J8geAH", "uri": "/contracts/b2MZ1J8geAH#development-and-commercialization", "label": "License Agreement (Cytrx Corp)", "score": 18.0, "published": true}, {"hash": "aGzCPn9BIt5", "uri": "/contracts/aGzCPn9BIt5#development-and-commercialization", "label": "License Agreement (Cytrx Corp)", "score": 18.0, "published": true}], "size": 11, "hash": "92d83e7c690fdf1f621a833514b9c378", "id": 4}, {"snippet_links": [{"key": "licensee-shall", "type": "clause", "offset": [0, 14]}, {"key": "obligation-to-develop", "type": "clause", "offset": [39, 60]}, {"key": "licensed-product", "type": "clause", "offset": [83, 99]}, {"key": "in-the-territory", "type": "clause", "offset": [100, 116]}, {"key": "of-licensee", "type": "clause", "offset": [176, 187]}, {"key": "development-activities", "type": "definition", "offset": [197, 219]}, {"key": "in-accordance-with", "type": "definition", "offset": [220, 238]}, {"key": "article-3", "type": "clause", "offset": [244, 253]}, {"key": "responsible-for", "type": "clause", "offset": [308, 323]}, {"key": "costs-and-expenses", "type": "clause", "offset": [328, 346]}, {"key": "in-connection-with", "type": "clause", "offset": [347, 365]}, {"key": "development-and-commercialization-activities", "type": "clause", "offset": [370, 414]}, {"key": "the-development", "type": "clause", "offset": [426, 441]}, {"key": "performed-by", "type": "clause", "offset": [453, 465]}], "snippet": "Licensee shall have the sole right and obligation to develop and commercialize the Licensed Product in the Territory. NovaDel shall perform or cause to be performed, on behalf of Licensee, certain Development Activities in accordance with this Article 3. 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