{"component": "clause", "props": {"groups": [{"samples": [{"hash": "fAzsmoKRzZv", "uri": "/contracts/fAzsmoKRzZv#manufacturing", "label": "General Terms and Conditions", "score": 30.987159729, "published": true}, {"hash": "59HAXetEFMd", "uri": "/contracts/59HAXetEFMd#manufacturing", "label": "Supply Agreement", "score": 30.6659526825, "published": true}, {"hash": "6mHekDy4lnJ", "uri": "/contracts/6mHekDy4lnJ#manufacturing", "label": "Purchase Agreement", "score": 30.5862960815, "published": true}], "size": 30, "snippet": "(a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.\n(b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser\u2019s express prior written approval.", "snippet_links": [{"key": "the-supplier-shall", "type": "clause", "offset": [4, 22]}, {"key": "without-limitation", "type": "clause", "offset": [23, 41]}, {"key": "be-responsible", "type": "clause", "offset": [42, 56]}, {"key": "no-additional-cost", "type": "clause", "offset": [61, 79]}, {"key": "raw-materials", "type": "clause", "offset": [130, 143]}, {"key": "all-necessary-approvals", "type": "clause", "offset": [172, 195]}, {"key": "permits-and-licenses", "type": "definition", "offset": [197, 217]}, {"key": "manufacturing-of-the-products", "type": "clause", "offset": [226, 255]}, {"key": "qualified-staff", "type": "definition", "offset": [278, 293]}, {"key": "the-obligations", "type": "clause", "offset": [317, 332]}, {"key": "this-purchase-agreement", "type": "clause", "offset": [339, 362]}, {"key": "control-procedures", "type": "clause", "offset": [428, 446]}, {"key": "with-respect-to", "type": "clause", "offset": [447, 462]}, {"key": "other-matters", "type": "clause", "offset": [490, 503]}, {"key": "by-the-purchaser", "type": "clause", "offset": [528, 544]}, {"key": "from-time-to-time", "type": "clause", "offset": [545, 562]}, {"key": "manufacturing-location", "type": "clause", "offset": [645, 667]}, {"key": "prior-written-approval", "type": "clause", "offset": [700, 722]}], "hash": "a1f683cc5d565def905e10602eb8cf46", "id": 1}, {"samples": [{"hash": "jDTZ2wOfu1C", "uri": "/contracts/jDTZ2wOfu1C#manufacturing", "label": "License Agreement (Checkpoint Therapeutics, Inc.)", "score": 27.5242977142, "published": true}, {"hash": "elvknFyTYBd", "uri": "/contracts/elvknFyTYBd#manufacturing", "label": "License Agreement (Checkpoint Therapeutics, Inc.)", "score": 27.3709793091, "published": true}, {"hash": "gizMheTuIY8", "uri": "/contracts/gizMheTuIY8#manufacturing", "label": "License Agreement (Checkpoint Therapeutics, Inc.)", "score": 27.2258720398, "published": true}], "size": 13, "snippet": "(a) Within sixty (60) days after the Effective Date, Cephalon (or its designee) and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the \u201cManufacturing and Supply Agreement\u201d), pursuant to which Cephalon shall, subject to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (\u201cAPI\u201d) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the \u201cInitial Supply Term\u201d). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products.\n(b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commission.", "snippet_links": [{"key": "after-the-effective-date", "type": "clause", "offset": [27, 51]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [95, 118]}, {"key": "to-enter", "type": "definition", "offset": [119, 127]}, {"key": "manufacturing-and-supply-agreement", "type": "definition", "offset": [135, 169]}, {"key": "pursuant-to", "type": "clause", "offset": [214, 225]}, {"key": "terms-of-the", "type": "clause", "offset": [263, 275]}, {"key": "manufacture-and-supply", "type": "clause", "offset": [316, 338]}, {"key": "have-manufactured", "type": "definition", "offset": [343, 360]}, {"key": "active-pharmaceutical-ingredient", "type": "definition", "offset": [386, 418]}, {"key": "drug-product", "type": "clause", "offset": [431, 443]}, {"key": "manufacturing-development-activities", "type": "definition", "offset": [510, 546]}, {"key": "each-case", "type": "definition", "offset": [595, 604]}, {"key": "requested-by", "type": "clause", "offset": [635, 647]}, {"key": "in-the-territory", "type": "clause", "offset": [657, 673]}, {"key": "initial-period", "type": "definition", "offset": [681, 695]}, {"key": "by-the-parties", "type": "clause", "offset": [712, 726]}, {"key": "initial-supply-term", "type": "definition", "offset": [780, 799]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [803, 832]}, {"key": "contracting-with-third-parties", "type": "clause", "offset": [908, 938]}, {"key": "to-manufacture", "type": "definition", "offset": [939, 953]}, {"key": "cost-and-expense", "type": "clause", "offset": [1233, 1249]}, {"key": "responsible-for", "type": "clause", "offset": [1260, 1275]}, {"key": "establishment-of", "type": "clause", "offset": [1307, 1323]}, {"key": "manufacturing-sources", "type": "clause", "offset": [1324, 1345]}, {"key": "licensed-compounds-and-licensed-products", "type": "clause", "offset": [1399, 1439]}, {"key": "in-the-field", "type": "clause", "offset": [1440, 1452]}, {"key": "provisions-of-this-section", "type": "clause", "offset": [1490, 1516]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [1541, 1576]}, {"key": "affiliates-and-sublicensees", "type": "clause", "offset": [1641, 1668]}, {"key": "activities-assigned", "type": "clause", "offset": [1688, 1707]}, {"key": "in-this-agreement", "type": "definition", "offset": [1714, 1731]}, {"key": "development-and-commercialization", "type": "clause", "offset": [1885, 1918]}, {"key": "in-accordance-with", "type": "clause", "offset": [2006, 2024]}, {"key": "good-manufacturing-practice", "type": "clause", "offset": [2025, 2052]}, {"key": "applicable-laws-and-standards", "type": "clause", "offset": [2061, 2090]}, {"key": "confidential-material", "type": "definition", "offset": [2094, 2115]}, {"key": "the-commission", "type": "clause", "offset": [2151, 2165]}], "hash": "3898f513e3c619d483bd1bd318460084", "id": 4}, {"samples": [{"hash": "g19HfeEjVZK", "uri": "/contracts/g19HfeEjVZK#manufacturing", "label": "Exclusive Channel Collaboration Agreement", "score": 31.3408622742, "published": true}, {"hash": "ijTO72TVB1f", "uri": "/contracts/ijTO72TVB1f#manufacturing", "label": "Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.)", "score": 27.8501033783, "published": true}, {"hash": "g5QOx0HpXAy", "uri": "/contracts/g5QOx0HpXAy#manufacturing", "label": "Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.)", "score": 25.3121147156, "published": true}], "size": 19, "snippet": "Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon\u2019s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.", "snippet_links": [{"key": "the-option", "type": "clause", "offset": [20, 30]}, {"key": "in-the-event", "type": "clause", "offset": [36, 48]}, {"key": "diligent-efforts", "type": "definition", "offset": [73, 89]}, {"key": "manufacturing-activities", "type": "definition", "offset": [106, 130]}, {"key": "in-connection-with", "type": "clause", "offset": [131, 149]}, {"key": "aquaculture-program", "type": "definition", "offset": [154, 173]}, {"key": "relate-to", "type": "definition", "offset": [179, 188]}, {"key": "intrexon-materials", "type": "definition", "offset": [193, 211]}, {"key": "contract-manufacturer", "type": "definition", "offset": [265, 286]}, {"key": "to-the-extent", "type": "clause", "offset": [288, 301]}, {"key": "a-separate", "type": "definition", "offset": [399, 409]}, {"key": "manufacturing-and-supply-agreement", "type": "definition", "offset": [410, 444]}, {"key": "the-production", "type": "clause", "offset": [488, 502]}, {"key": "quality-assurance", "type": "clause", "offset": [504, 521]}, {"key": "regulatory-activities", "type": "clause", "offset": [527, 548]}, {"key": "associated-with", "type": "definition", "offset": [549, 564]}, {"key": "except-as-provided-in", "type": "clause", "offset": [600, 621]}, {"key": "section-41", "type": "clause", "offset": [622, 633]}, {"key": "pursuant-to-the", "type": "definition", "offset": [676, 691]}, {"key": "cash-payments", "type": "clause", "offset": [746, 759]}, {"key": "equal-to", "type": "definition", "offset": [760, 768]}, {"key": "fully-loaded-cost", "type": "clause", "offset": [780, 797]}, {"key": "terms-to-be-negotiated", "type": "clause", "offset": [840, 862]}, {"key": "by-the-parties", "type": "clause", "offset": [863, 877]}, {"key": "in-good-faith", "type": "definition", "offset": [878, 891]}, {"key": "other-components", "type": "clause", "offset": [982, 998]}, {"key": "provide-to", "type": "clause", "offset": [1043, 1053]}, {"key": "approved-by", "type": "clause", "offset": [1119, 1130]}, {"key": "all-information", "type": "clause", "offset": [1188, 1203]}, {"key": "related-to", "type": "definition", "offset": [1239, 1249]}, {"key": "in-the-field", "type": "clause", "offset": [1364, 1376]}, {"key": "reasonably-necessary", "type": "clause", "offset": [1385, 1405]}, {"key": "purpose-of", "type": "clause", "offset": [1487, 1497]}, {"key": "expenses-incurred", "type": "definition", "offset": [1613, 1630]}, {"key": "manufacturing-information", "type": "clause", "offset": [1705, 1730]}, {"key": "product-sublicensee", "type": "definition", "offset": [1863, 1882]}, {"key": "consent-of", "type": "clause", "offset": [1938, 1948]}], "hash": "c1832cbdda3c23eed84c13505cb5f0df", "id": 2}, {"samples": [{"hash": "eqgtMpj78Xc", "uri": "/contracts/eqgtMpj78Xc#manufacturing", "label": "License and Commercialization Agreement (Bellerophon Therapeutics LLC)", "score": 26.032169342, "published": true}, {"hash": "117iSGFYTmU", "uri": "/contracts/117iSGFYTmU#manufacturing", "label": "License and Commercialization Agreement (Bellerophon Therapeutics LLC)", "score": 25.3641338348, "published": true}, {"hash": "fxrFfrdjSo6", "uri": "/contracts/fxrFfrdjSo6#manufacturing", "label": "License and Commercialization Agreement (Ikaria, Inc.)", "score": 21.7419567108, "published": true}], "size": 13, "snippet": "(a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees.\n(b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [**] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [**], provided that the price shall not exceed [**] percent ([**]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost.\n(c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the \u201cJoint Manufacturing Committee\u201d or \u201cJMC\u201d) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [**] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party.\n(d) The JMC would meet at least [**] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC.\n(e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties\u2019 respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria\u2019s Executive Officer shall have the right to decide the matter taking into account Ikaria\u2019s obligation to use Commercially Reasonable Efforts under Section 3.8.", "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [27, 42]}, {"key": "manufacture-of-products", "type": "clause", "offset": [47, 70]}, {"key": "for-development", "type": "clause", "offset": [71, 86]}, {"key": "commercialization-in-the-field-in-the-territory", "type": "clause", "offset": [94, 141]}, {"key": "the-option", "type": "clause", "offset": [241, 251]}, {"key": "an-affiliate", "type": "clause", "offset": [280, 292]}, {"key": "sole-discretion", "type": "definition", "offset": [314, 329]}, {"key": "prior-to-the", "type": "clause", "offset": [356, 368]}, {"key": "to-file", "type": "definition", "offset": [398, 405]}, {"key": "regulatory-approval", "type": "definition", "offset": [410, 429]}, {"key": "the-us", "type": "clause", "offset": [433, 440]}, {"key": "to-manufacture", "type": "definition", "offset": [443, 457]}, {"key": "terms-of", "type": "clause", "offset": [482, 490]}, {"key": "to-be-negotiated", "type": "clause", "offset": [510, 526]}, {"key": "in-good-faith", "type": "definition", "offset": [527, 540]}, {"key": "by-the-parties", "type": "clause", "offset": [541, 555]}, {"key": "provided-that", "type": "definition", "offset": [557, 570]}, {"key": "the-foregoing", "type": "definition", "offset": [598, 611]}, {"key": "option-only", "type": "clause", "offset": [612, 623]}, {"key": "to-the-extent", "type": "clause", "offset": [624, 637]}, {"key": "ability-to", "type": "definition", "offset": [667, 677]}, {"key": "the-product", "type": "definition", "offset": [690, 701]}, {"key": "compliance-with-cgmp", "type": "clause", "offset": [713, 733]}, {"key": "all-applicable-laws-and-regulations", "type": "definition", "offset": [738, 773]}, {"key": "the-fda", "type": "clause", "offset": [794, 801]}, {"key": "to-establish", "type": "definition", "offset": [860, 872]}, {"key": "manufacturing-site", "type": "definition", "offset": [899, 917]}, {"key": "costs-of", "type": "clause", "offset": [933, 941]}, {"key": "process-validation-batches", "type": "definition", "offset": [960, 986]}, {"key": "neither-party-shall", "type": "clause", "offset": [1120, 1139]}, {"key": "to-enter", "type": "definition", "offset": [1160, 1168]}, {"key": "the-terms-and-conditions", "type": "clause", "offset": [1203, 1227]}, {"key": "both-parties", "type": "definition", "offset": [1254, 1266]}, {"key": "requirements-for-the", "type": "clause", "offset": [1437, 1457]}, {"key": "per-unit-price", "type": "definition", "offset": [1494, 1508]}, {"key": "the-price", "type": "clause", "offset": [1558, 1567]}, {"key": "unit-of-product", "type": "definition", "offset": [1633, 1648]}, {"key": "at-any-time", "type": "clause", "offset": [1687, 1698]}, {"key": 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"each-party", "type": "definition", "offset": [2473, 2483]}, {"key": "designation-of", "type": "clause", "offset": [2507, 2521]}, {"key": "days-after", "type": "definition", "offset": [2562, 2572]}, {"key": "agreed-to", "type": "clause", "offset": [2585, 2594]}, {"key": "experience-and-knowledge", "type": "clause", "offset": [2699, 2723]}, {"key": "to-discuss", "type": "definition", "offset": [2724, 2734]}, {"key": "notice-to-the", "type": "clause", "offset": [2873, 2886]}, {"key": "other-party", "type": "definition", "offset": [2887, 2898]}, {"key": "location-of", "type": "clause", "offset": [2990, 3001]}, {"key": "agreed-by", "type": "clause", "offset": [3037, 3046]}, {"key": "conference-call", "type": "definition", "offset": [3115, 3130]}, {"key": "to-attend", "type": "clause", "offset": [3201, 3210]}, {"key": "meetings-of-the-jmc", "type": "clause", "offset": [3215, 3234]}, {"key": "a-party", "type": "clause", "offset": [3259, 3266]}, {"key": "such-party", "type": "clause", "offset": [3298, 3308]}, {"key": "place-of", "type": "clause", "offset": [3362, 3370]}, {"key": "own-costs", "type": "clause", "offset": [3424, 3433]}, {"key": "with-respect-to", "type": "clause", "offset": [3434, 3449]}, {"key": "executive-officers", "type": "definition", "offset": [3671, 3689]}, {"key": "the-executive", "type": "clause", "offset": [3709, 3722]}, {"key": "right-to", "type": "definition", "offset": [3864, 3872]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [3934, 3969]}, {"key": "section-38", "type": "clause", "offset": [3976, 3987]}], "hash": "1d6968f7e67bf34e29ebe8f0ea574ecf", "id": 3}, {"samples": [{"hash": "itQLCfaw3fH", "uri": "/contracts/itQLCfaw3fH#manufacturing", "label": "License Agreement (Bellicum Pharmaceuticals, Inc)", "score": 31.8446273804, "published": true}, {"hash": "lKlcvnRRQ5c", "uri": "/contracts/lKlcvnRRQ5c#manufacturing", "label": "License Agreement (Bellicum Pharmaceuticals, Inc)", "score": 25.8788509369, "published": true}, {"hash": "4CotIe6u3NQ", "uri": "/contracts/4CotIe6u3NQ#manufacturing", "label": "License Agreement (Bellicum Pharmaceuticals, Inc)", "score": 25.7912387848, "published": true}], "size": 10, "snippet": "Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least [\u2026***\u2026] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD\u2019s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide [\u2026***\u2026] rolling [\u2026***\u2026] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD\u2019s licensees on at a price equal to fully burdened manufacturing costs plus [\u2026***\u2026] percent ([\u2026***\u2026]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD\u2019s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.", "snippet_links": [{"key": "right-to-manufacture", "type": "clause", "offset": [24, 44]}, {"key": "have-manufactured", "type": "definition", "offset": [48, 65]}, {"key": "to-develop", "type": "definition", "offset": [126, 136]}, {"key": "licensed-product", "type": "clause", "offset": [159, 175]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [192, 215]}, {"key": "in-writing", "type": "clause", "offset": [244, 254]}, {"key": "intent-to-manufacture", "type": "definition", "offset": [262, 283]}, {"key": "by-a-third-party", "type": "clause", "offset": [306, 322]}, {"key": "commencement-of", "type": "clause", "offset": [364, 379]}, {"key": "at-any-time", "type": "clause", "offset": [449, 460]}, {"key": "the-parties-will", "type": "clause", "offset": [462, 478]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [479, 502]}, {"key": "will-provide", "type": "clause", "offset": [540, 552]}, {"key": "number-of-months", "type": "definition", "offset": [650, 666]}, {"key": "provided-that", "type": "definition", "offset": [684, 697]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [753, 788]}, {"key": "ordered-by", "type": "definition", "offset": [827, 837]}, {"key": "equal-to", "type": "definition", "offset": [920, 928]}, {"key": "fully-burdened-manufacturing-costs", "type": "definition", "offset": [929, 963]}, {"key": "right-to-purchase", "type": "clause", "offset": [1142, 1159]}, {"key": "the-third-party", "type": "definition", "offset": [1181, 1196]}, {"key": "less-favorable", "type": "definition", "offset": [1209, 1223]}, {"key": "granted-to", "type": "definition", "offset": [1235, 1245]}, {"key": "equal-priority", "type": "clause", "offset": [1302, 1316]}, {"key": "with-respect-to", "type": "clause", "offset": [1317, 1332]}, {"key": "delivery-of", "type": "clause", "offset": [1359, 1370]}, {"key": "all-licenses", "type": "clause", "offset": [1481, 1493]}, {"key": "patent-rights-and-technology", "type": "clause", "offset": [1497, 1525]}, {"key": "additional-expense", "type": "definition", "offset": [1577, 1595]}, {"key": "third-party-licensors", "type": "definition", "offset": [1614, 1635]}, {"key": "in-addition", "type": "clause", "offset": [1757, 1768]}, {"key": "the-supply-agreement", "type": "clause", "offset": [1770, 1790]}, {"key": "third-party-manufacturer", "type": "clause", "offset": [1829, 1853]}, {"key": "as-required", "type": "clause", "offset": [1880, 1891]}, {"key": "transfer-to", "type": "definition", "offset": [1947, 1958]}, {"key": "all-necessary-licenses", "type": "clause", "offset": [2051, 2073]}, {"key": "fee-basis", "type": "definition", "offset": [2112, 2121]}], "hash": "0402c32f2f5596d49f8d50d28c3fdb3e", "id": 9}, {"samples": [{"hash": "aiXLmDfQfRz", "uri": "/contracts/aiXLmDfQfRz#manufacturing", "label": "Agreement (Gen Probe Inc)", "score": 18.0, "published": true}, {"hash": "30EYxqsoYph", "uri": "/contracts/30EYxqsoYph#manufacturing", "label": "Agreement (Gen Probe Inc)", "score": 18.0, "published": true}], "size": 13, "snippet": "(a) Subject to Section 4.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory for use in the Clinical Diagnostic Field in accordance with Article 6 below.\n(b) If Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for an Initial Clinical Diagnostic Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at its option, to manufacture (or to have manufactured) its requirements of such Initial Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Initial Clinical Diagnostic Assay in accordance with Article 6 below. In such event, Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Initial Clinical Diagnostic Assay.\n(c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate.\n(d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.1.3(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively.\n(e) If either party exercises any right granted hereunder to have any Initial Clinical Diagnostic Assay manufactured, then (i) such party shall first require that the subcontracted party shall enter into a confidentiality agreement with such party incorporating the terms of Article 8 below; (ii) such party shall supervise such subcontract work; (iii) the subcontracted party shall comply in all material respects with all requirements of applicable laws and regulations, together with all applicable good laboratory, clinical and manufacturing practices; and (iv) the subcontracted party shall enter into an agreement with such party to the extent necessary to effectuate the provisions of Article 9 below.", "snippet_links": [{"key": "subject-to-section", "type": "clause", "offset": [4, 22]}, {"key": "the-obligation", "type": "clause", "offset": [84, 98]}, {"key": "have-manufactured", "type": "definition", "offset": [121, 138]}, {"key": "requirements-for-the", "type": "clause", "offset": [173, 193]}, {"key": "in-the-territory", "type": "clause", "offset": [229, 245]}, {"key": "clinical-diagnostic-field", "type": "definition", "offset": [261, 286]}, {"key": "in-accordance-with", "type": "clause", "offset": [287, 305]}, {"key": "article-6", "type": "definition", "offset": [306, 315]}, {"key": "requested-delivery-date", "type": "definition", "offset": [398, 421]}, {"key": "monthly-requirements", "type": "clause", "offset": [436, 456]}, {"key": "the-right", "type": "clause", "offset": [649, 658]}, {"key": "to-the-extent", "type": "clause", "offset": [913, 926]}, {"key": "rare-reagents", "type": "clause", "offset": [979, 992]}, {"key": "this-agreement", "type": "clause", "offset": [1012, 1026]}, {"key": "exclusive-right-to-manufacture", "type": "clause", "offset": [1055, 1085]}, {"key": "obligation-to-supply", "type": "clause", "offset": [1120, 1140]}, {"key": "requirements-of-the", "type": "clause", "offset": [1157, 1176]}, {"key": "technical-assistance", "type": "clause", "offset": [1341, 1361]}, {"key": "to-exercise", "type": "clause", "offset": [1419, 1430]}, {"key": "finished-goods", "type": "definition", "offset": [1578, 1592]}, {"key": "safety-stock", "type": "definition", "offset": [1593, 1605]}, {"key": "board-shall", "type": "definition", "offset": [1784, 1795]}, {"key": "the-safety", "type": "clause", "offset": [1846, 1856]}, {"key": "by-each-party", "type": "clause", "offset": [1868, 1881]}, {"key": "notice-of", "type": "definition", "offset": [1944, 1953]}, {"key": "issued-by", "type": "clause", "offset": [1981, 1990]}, {"key": "section-634", "type": "clause", "offset": [2013, 2026]}, {"key": "prior-to", "type": "definition", "offset": [2114, 2122]}, {"key": "manufacturing-responsibilities", "type": "definition", "offset": [2146, 2176]}, {"key": "meet-and-discuss", "type": "definition", "offset": [2206, 2222]}, {"key": "in-good-faith", "type": "definition", "offset": [2223, 2236]}, {"key": "quality-requirements", "type": "definition", "offset": [2331, 2351]}, {"key": "of-the-parties", "type": "clause", "offset": [2352, 2366]}, {"key": "least-cost", "type": "definition", "offset": [2374, 2384]}, {"key": "if-either-party", "type": "clause", "offset": [2418, 2433]}, {"key": "right-granted", "type": "clause", "offset": [2448, 2461]}, {"key": "such-party", "type": "clause", "offset": [2541, 2551]}, {"key": "confidentiality-agreement", "type": "clause", "offset": [2620, 2645]}, {"key": "terms-of", "type": "clause", "offset": [2680, 2688]}, {"key": "article-8", "type": "definition", "offset": [2689, 2698]}, {"key": "subcontract-work", "type": "clause", "offset": [2743, 2759]}, {"key": "in-all-material-respects", "type": "definition", "offset": [2804, 2828]}, {"key": "all-requirements", "type": "clause", "offset": [2834, 2850]}, {"key": "applicable-laws-and-regulations", "type": "clause", "offset": [2854, 2885]}, {"key": "manufacturing-practices", "type": "clause", "offset": [2946, 2969]}, {"key": "an-agreement", "type": "clause", "offset": [3021, 3033]}, {"key": "article-9", "type": "definition", "offset": [3106, 3115]}], "hash": "2cf025282f35f9413ca6faafa63cc82c", "id": 5}, {"samples": [{"hash": "3TEjtXg2wyf", "uri": "/contracts/3TEjtXg2wyf#manufacturing", "label": "Supply Agreement (Allergan Inc)", "score": 18.0, "published": true}], "size": 11, "snippet": "(a) ALLERGAN shall only Manufacture the Product at the Secondary Manufacturing Facilities and the API at the API Manufacturing Facilities. ***, all Product shall be supplied to GSK from ALLERGAN's Secondary Manufacturing Facility***. GSK acknowledges that ALLERGAN intends to add, within the next three years, an additional production line at the Secondary Manufacturing Facility at Westport, Ireland, (\"CORE 3\") and an additional API Manufacturing Facility. If ALLERGAN wishes to change the facility at which ALLERGAN Manufactures Product or API or add additional facilities at which ALLERGAN Manufactures Product or API, ALLERGAN shall provide GSK with prior written notice to that effect in order to allow GSK to comply with its regulatory and legal obligations and obtain any necessary approvals from a Regulatory Authority of amendments to Marketing Authorizations in relation to such a change. Any changes to the Manufacturing Facilities that cause a Product Change will be dealt with in accordance with the Change Control procedure set out in Section 2.5. Notwithstanding the foregoing, ALLERGAN shall supply GSK with Product pursuant to Marketing Authorizations for the Territory, and ALLERGAN shall maintain sufficient supplies of approved Product to supply GSK its requirements for the Territory until approvals from a Regulatory Authority of amendments to Marketing Authorization in the Territory is obtained for any changes to the Manufacturing Facilities. ALLERGAN shall obtain any necessary Manufacturing Authorizations from the Regulatory Authority in the country of Manufacture prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities. ALLERGAN will be solely responsible for obtaining necessary Manufacturing Authorizations in *** Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the country of Manufacture for Manufacturing the Product at any Secondary Manufacturing Facility and the API at any API Manufacturing Facility. GSK shall obtain (with reasonable assistance from ALLERGAN) any necessary Marketing Authorizations from the Regulatory Authority in the Territory prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities. GSK shall be diligent in its efforts to obtain approvals from a Regulatory Authority of amendments to Marketing Authorizations in the Territory to any Product Changes, with the support of ALLERGAN, in order to ensure that ALLERGAN may implement such Product Changes as soon as possible. ALLERGAN shall be diligent in its efforts to obtain Manufacturing Authorization in the country of Manufacture to any Product Changes, with the support of GSK, in order to ensure that ALLERGAN may implement such Product Changes as soon as possible.\n(b) ALLERGAN shall be solely responsible for ordering the relevant quantities of Materials and for the timely delivery of such Materials. ALLERGAN shall purchase and use only Materials in the Manufacture of the Product which comply with the requirements of cGMP, the Manufacturing Authorizations and Marketing Authorization, and which have been tested in accordance with the Marketing Authorisation and applicable law in the Territory. Any changes to the suppliers of Materials that cause a Product Change will be dealt with in accordance with the Change Control procedure set out in Section 2.5. ALLERGAN shall at all times store and warehouse all Materials and Products Manufactured by ALLERGAN pursuant to this Supply Agreement in premises that are secure and clean.", "snippet_links": [{"key": "manufacturing-facilities", "type": "clause", "offset": [65, 89]}, {"key": "api-manufacturing", "type": "definition", "offset": [109, 126]}, {"key": "manufacturing-facility", "type": "clause", "offset": [207, 229]}, {"key": "an-additional", "type": "clause", "offset": [310, 323]}, {"key": "production-line", "type": "clause", "offset": [324, 339]}, {"key": "the-facility", "type": "clause", "offset": [488, 500]}, {"key": "additional-facilities", "type": "definition", "offset": [554, 575]}, {"key": "notice-to", "type": "definition", "offset": [669, 678]}, {"key": "legal-obligations", "type": "definition", "offset": [747, 764]}, {"key": "necessary-approvals", "type": "definition", "offset": [780, 799]}, {"key": "regulatory-authority", "type": "clause", "offset": [807, 827]}, {"key": "amendments-to", "type": "clause", "offset": [831, 844]}, {"key": "marketing-authorizations", "type": "clause", "offset": [845, 869]}, {"key": "in-relation-to", "type": "clause", "offset": [870, 884]}, {"key": "a-change", "type": "clause", "offset": [890, 898]}, {"key": "changes-to-the", "type": "definition", "offset": [904, 918]}, {"key": "in-accordance-with", "type": "clause", "offset": [991, 1009]}, {"key": "change-control-procedure", "type": "clause", "offset": [1014, 1038]}, {"key": "set-out", "type": "definition", "offset": [1039, 1046]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [1063, 1092]}, {"key": "approved-product", "type": "definition", "offset": [1240, 1256]}, {"key": "requirements-for-the", "type": "clause", "offset": [1275, 1295]}, {"key": "in-the-territory", "type": "clause", "offset": [1391, 1407]}, {"key": "country-of-manufacture", "type": "clause", "offset": [1571, 1593]}, {"key": "prior-to", "type": "definition", "offset": [1594, 1602]}, {"key": "modifications-to-the", "type": "clause", "offset": [1607, 1627]}, {"key": "responsible-for", "type": "clause", "offset": [1720, 1735]}, {"key": "certain-confidential-information", "type": "clause", "offset": [1792, 1824]}, {"key": "contained-in", "type": "definition", "offset": [1825, 1837]}, {"key": "omitted-and-filed-separately-with-the-securities-and-exchange-commission", "type": "clause", "offset": [1887, 1959]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [1960, 1976]}, {"key": "securities-exchange-act-of-1934", "type": "definition", "offset": [1990, 2021]}, {"key": "as-amended", "type": "definition", "offset": [2023, 2033]}, {"key": "reasonable-assistance", "type": "clause", "offset": [2202, 2223]}, {"key": "obtain-approvals", "type": "clause", "offset": [2467, 2483]}, {"key": "product-changes", "type": "definition", "offset": [2578, 2593]}, {"key": "in-order-to-ensure", "type": "clause", "offset": [2625, 2643]}, {"key": "as-soon-as-possible", "type": "definition", "offset": [2693, 2712]}, {"key": "manufacturing-authorization", "type": "definition", "offset": [2766, 2793]}, {"key": "the-relevant", "type": "clause", "offset": [3016, 3028]}, {"key": "quantities-of-materials", "type": "clause", "offset": [3029, 3052]}, {"key": "delivery-of", "type": "clause", "offset": [3072, 3083]}, {"key": "manufacture-of-the-product", "type": "clause", "offset": [3154, 3180]}, {"key": "the-requirements", "type": "clause", "offset": [3199, 3215]}, {"key": "marketing-authorisation", "type": "clause", "offset": [3337, 3360]}, {"key": "applicable-law", "type": "definition", "offset": [3365, 3379]}, {"key": "at-all-times", "type": "clause", "offset": [3574, 3586]}, {"key": "materials-and-products", "type": "clause", "offset": [3611, 3633]}, {"key": "by-allergan", "type": "clause", "offset": [3647, 3658]}, {"key": "supply-agreement", "type": "clause", "offset": [3676, 3692]}], "hash": "21d46d8531f5eb66fd39c7592b71d8c2", "id": 8}, {"samples": [{"hash": "ixNwZX1Bmqj", "uri": "/contracts/ixNwZX1Bmqj#manufacturing", "label": "License and Development Agreement (Novadel Pharma Inc)", "score": 18.0, "published": true}, {"hash": "hIa6pmXBWR9", "uri": "/contracts/hIa6pmXBWR9#manufacturing", "label": "License and Development Agreement (Manhattan Pharmaceuticals Inc)", "score": 18.0, "published": true}, {"hash": "9eorkb3gkl2", "uri": "/contracts/9eorkb3gkl2#manufacturing", "label": "License and Development Agreement (Novadel Pharma Inc)", "score": 18.0, "published": true}], "size": 11, "snippet": "3.11.1 Subject to section 3.11.4, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms for clinical development of the Licensed Product pursuant to a manufacturing agreement (the \"Manufacturing Agreement\") to be entered into following execution of this Agreement.\n3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement.\n3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it will act in accordance with GMP and all applicable laws, rules and regulations.\n3.11.4 The manufacturing agreement will provide among other things that in the event that Licensee enters into a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as set forth in section 3.11.5\n3.11.5 It is the intent of the Parties that NovaDel be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture of the Licensed Product and the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong to NovaDel.", "snippet_links": [{"key": "subject-to-section", "type": "clause", "offset": [7, 25]}, {"key": "supply-licensee", "type": "definition", "offset": [64, 79]}, {"key": "terms-for", "type": "definition", "offset": [129, 138]}, {"key": "development-of-the-licensed-product", "type": "clause", "offset": [148, 183]}, {"key": "pursuant-to-a", "type": "clause", "offset": [184, 197]}, {"key": "manufacturing-agreement", "type": "definition", "offset": [198, 221]}, {"key": "entered-into", "type": "clause", "offset": [260, 272]}, {"key": "execution-of-this-agreement", "type": "clause", "offset": [283, 310]}, {"key": "receipt-of-regulatory-approval", "type": "clause", "offset": [356, 386]}, {"key": "at-all-times", "type": "clause", "offset": [558, 570]}, {"key": "the-performance", "type": "clause", "offset": [578, 593]}, {"key": "development-activities", "type": "clause", "offset": [601, 623]}, {"key": "in-accordance-with", "type": "clause", "offset": [637, 655]}, {"key": "all-applicable-laws", "type": "definition", "offset": [664, 683]}, {"key": "rules-and-regulations", "type": "definition", "offset": [685, 706]}, {"key": "will-provide", "type": "clause", "offset": [743, 755]}, {"key": "in-the-event", "type": "clause", "offset": [780, 792]}, {"key": "obtain-rights", "type": "clause", "offset": [887, 900]}, {"key": "to-manufacture", "type": "definition", "offset": [901, 915]}, {"key": "consent-to-transfer", "type": "clause", "offset": [987, 1006]}, {"key": "manufacturing-rights", "type": "clause", "offset": [1011, 1031]}, {"key": "provided-that", "type": "definition", "offset": [1053, 1066]}, {"key": "agreement-to-continue", "type": "clause", "offset": [1115, 1136]}, {"key": "with-respect-to", "type": "clause", "offset": [1205, 1220]}, {"key": "intent-of-the-parties", "type": "clause", "offset": [1290, 1311]}, {"key": "exclusive-manufacturer", "type": "clause", "offset": [1332, 1354]}, {"key": "terms-of-the", "type": "clause", "offset": [1395, 1407]}, {"key": "to-provide", "type": "definition", "offset": [1506, 1516]}, {"key": "commercial-supply-of-licensed-product", "type": "clause", "offset": [1529, 1566]}, {"key": "reasonable-period-of-time", "type": "clause", "offset": [1576, 1601]}, {"key": "licensee-shall", "type": "clause", "offset": [1643, 1657]}, {"key": "manufacturing-source", "type": "clause", "offset": [1688, 1708]}, {"key": "use-commercially-reasonable-efforts", "type": "clause", "offset": [1740, 1775]}, {"key": "to-ensure", "type": "clause", "offset": [1776, 1785]}, {"key": "to-maintain", "type": "clause", "offset": [1841, 1852]}, {"key": "strictest-confidence", "type": "clause", "offset": [1856, 1876]}, {"key": "all-information", "type": "clause", "offset": [1877, 1892]}, {"key": "relating-to", "type": "definition", "offset": [1893, 1904]}, {"key": "manufacture-of-the-licensed-product", "type": "clause", "offset": [1909, 1944]}, {"key": "licensed-technology", "type": "clause", "offset": [1953, 1972]}, {"key": "to-file", "type": "definition", "offset": [1982, 1989]}, {"key": "intellectual-property-protection", "type": "clause", "offset": [1994, 2026]}, {"key": "arise-from", "type": "definition", "offset": [2059, 2069]}], "hash": "43cb5bb7a1b519eb463bca4fc33d8fe4", "id": 7}, {"samples": [{"hash": "FqP4X806I2", "uri": "/contracts/FqP4X806I2#manufacturing", "label": "Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.)", "score": 32.5373039246, "published": true}, {"hash": "21YulHc3wiS", "uri": "/contracts/21YulHc3wiS#manufacturing", "label": "Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.)", "score": 32.4031486511, "published": true}, {"hash": "1amo6onApO", "uri": "/contracts/1amo6onApO#manufacturing", "label": "Exclusive Channel Collaboration Agreement (Fibrocell Science, Inc.)", "score": 24.2470912933, "published": true}], "size": 12, "snippet": "Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Fibroblast Program that relate to the Intrexon Materials. To the extent that Intrexon so elects, Intrexon may request that Fibrocell and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon\u2019s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Products, for use in the Field and is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell to switch manufacturers. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 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This Section 1.5 shall not be deemed to be an agreement by the Parties for such manufacture and the Parties shall not have any obligations with respect thereto unless and until a written agreement has been duly executed.", "snippet_links": [{"key": "the-parties-acknowledge-and-agree-that", "type": "clause", "offset": [0, 38]}, {"key": "mutual-intention", "type": "clause", "offset": [59, 75]}, {"key": "entering-into", "type": "clause", "offset": [114, 127]}, {"key": "written-agreement", "type": "definition", "offset": [130, 147]}, {"key": "provide-for", "type": "definition", "offset": [239, 250]}, {"key": "certain-products", "type": "clause", "offset": [270, 286]}, {"key": "in-the-territory", "type": "clause", "offset": [287, 303]}, {"key": "agreement-by-the-parties", "type": "clause", "offset": [351, 375]}, {"key": "the-parties-shall", "type": "clause", "offset": [401, 418]}, {"key": "duly-executed", "type": "clause", "offset": [511, 524]}], "hash": "f02e6ebdd48ac1c8de9b1042e5becc6b", "id": 10}], "next_curs": "ClYSUGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjILEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhZtYW51ZmFjdHVyaW5nIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Manufacturing", "children": [["", ""], ["manufacturing-technology-transfer", "Manufacturing Technology Transfer"], ["general", "General"], ["commercial-supply", "Commercial Supply"], ["manufacturing", "Manufacturing"]], "parents": [["manufacturing", "Manufacturing"], ["other-rights-and-obligations", "Other Rights and Obligations"], ["term-and-termination", "Term and Termination"], ["whereas", "WHEREAS"], ["development-and-commercialization", "Development and Commercialization"]], "size": 2083, "id": "manufacturing", "related": [["manufacture", "Manufacture", "Manufacture"], ["manufacturing-services", "Manufacturing Services", "<strong>Manufacturing</strong> Services"], ["commercialization", "Commercialization", "Commercialization"], ["product", "Product", "Product"], ["fabrication", "Fabrication", "Fabrication"]], "related_snippets": [], "updated": "2026-06-24T04:23:54+00:00", "also_ask": ["What key performance metrics should be mandated in a manufacturing clause?", "How can liability for defects or delays be strategically allocated?", "What are the most common enforceability challenges in manufacturing agreements?", "How do manufacturing clauses differ across jurisdictions or industries?", "Which terms are essential to prevent supply chain disruptions?"], "drafting_tip": "Specify manufacturing standards to ensure product quality, define delivery timelines to prevent delays, and require compliance with laws to mitigate legal risks.", "explanation": "The Manufacturing clause defines the obligations and standards related to the production of goods under the agreement. It typically outlines requirements such as quality control, compliance with specifications, timelines for production, and adherence to applicable laws and regulations. For example, it may specify that products must be manufactured in accordance with certain industry standards or that the manufacturer must allow inspections by the buyer. The core function of this clause is to ensure that the goods produced meet agreed-upon criteria, thereby reducing the risk of defective or non-compliant products and providing clear expectations for both parties."}, "json": true, "cursor": ""}}