{"component": "clause", "props": {"groups": [{"snippet": "Catalent shall, at Client\u2019s option, either (A) replace at its cost another Batch of Product (as a replacement for any Batch of Defective Product attributable to Catalent Defective Processing) using Client-supplied Materials provided at Client\u2019s cost or (B) credit any payments made by Client for such Batch. THE OBLIGATION OF CATALENT TO REPLACE CATALENT DEFECTIVE PROCESSING IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT FOR DEFECTIVE PRODUCT ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING SHALL BE CLIENT\u2019S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.", "size": 3, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [127, 144]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [161, 190]}, {"key": "materials-provided", "type": "clause", "offset": [214, 232]}, {"key": "by-client", "type": "clause", "offset": [282, 291]}, {"key": "the-obligation", "type": "clause", "offset": [308, 322]}, {"key": "in-accordance-with", "type": "definition", "offset": [376, 394]}, {"key": "the-specifications", "type": "definition", "offset": [395, 413]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [534, 559]}, {"key": "agreement-for", "type": "clause", "offset": [571, 584]}, {"key": "in-lieu-of", "type": "clause", "offset": [610, 620]}, {"key": "other-warranty", "type": "clause", "offset": [625, 639]}], "samples": [{"hash": "1KfnMZC16DH", "uri": "/contracts/1KfnMZC16DH#defective-processing", "label": "Softgel Commercial Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "5JhlwcLpyQT", "uri": "/contracts/5JhlwcLpyQT#defective-processing", "label": "Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)", "score": 30.1553730322, "published": true}, {"hash": "fl4beoRHZn4", "uri": "/contracts/fl4beoRHZn4#defective-processing", "label": "Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)", "score": 29.5749486653, "published": true}], "hash": "ec8e85a40280d9cf626ef6a654f5b2e6", "id": 1}, {"snippet": "Catalent shall, [**], either (A) if requested or approved by Client, re-Process (or if re-Processing is not permissible under cGMPs, then replace), at its cost any Batch of Defective Product attributable to Catalent Defective Processing (and Client shall be liable to pay for either the rejected Batch (es) or the replacement Batch (es), but not both), or (B) credit any payments made by Client for such rejected Batch. TOE OBLIGATION OF CATALENT TO RE-PROCESS (OR REPLACE) DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT, IN EACH CASE, WHICH IS ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING SHALL BE, TOGETHER WITH CLIENT\u2019S RIGHTS UNDER SECTIONS 13.1 AND 16.2B, CLIENT\u2019S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. In the event of Catalent Defective Processing with respect to [**] or more separate instances in any [**] month period, Client may terminate this Agreement or any Order pursuant to 16.2(B) upon notice to Catalent and without any obligation to provide a further opportunity to cure. For the avoidance of doubt, in the event that in the course of a manufacturing campaign in which more than one Batch is Processed and all of the Batches thereunder are subject to Catalent Defective Processing, such event shall be deemed as a single instance hereunder and not an instance for each Batch in such campaign that may be affected.", "size": 3, "snippet_links": [{"key": "by-client", "type": "clause", "offset": [58, 67]}, {"key": "defective-product", "type": "definition", "offset": [173, 190]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [207, 236]}, {"key": "client-shall", "type": "clause", "offset": [242, 254]}, {"key": "pay-for", "type": "clause", "offset": [268, 275]}, {"key": "replacement-batch", "type": "definition", "offset": [314, 331]}, {"key": "payments-made-by", "type": "clause", "offset": [371, 387]}, {"key": "in-accordance-with", "type": "definition", "offset": [492, 510]}, {"key": "the-specifications", "type": "definition", "offset": [511, 529]}, {"key": "each-case", "type": "definition", "offset": [568, 577]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [714, 739]}, {"key": "agreement-for", "type": "clause", "offset": [751, 764]}, {"key": "in-lieu-of", "type": "clause", "offset": [790, 800]}, {"key": "other-warranty", "type": "clause", "offset": [805, 819]}, {"key": "in-the-event-of", "type": "definition", "offset": [841, 856]}, {"key": "with-respect-to", "type": "clause", "offset": [887, 902]}, {"key": "agreement-or", "type": "definition", "offset": [987, 999]}, {"key": "any-order", "type": "definition", "offset": [1000, 1009]}, {"key": "pursuant-to", "type": "definition", "offset": [1010, 1021]}, {"key": "notice-to", "type": "definition", "offset": [1035, 1044]}, {"key": "provide-a", "type": "definition", "offset": [1084, 1093]}, {"key": "further-opportunity-to-cure", "type": "clause", "offset": [1094, 1121]}, {"key": "for-the-avoidance-of-doubt", "type": "clause", "offset": [1123, 1149]}, {"key": "in-the-course-of", "type": "definition", "offset": [1169, 1185]}, {"key": "subject-to", "type": "definition", "offset": [1291, 1301]}, {"key": "single-instance", "type": "definition", "offset": [1365, 1380]}], "samples": [{"hash": "5ulhpUHlDiI", "uri": "/contracts/5ulhpUHlDiI#defective-processing", "label": "Commercial Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "4iW2y2DtRCp", "uri": "/contracts/4iW2y2DtRCp#defective-processing", "label": "Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)", "score": 28.4743326489, "published": true}, {"hash": "8wcNqc4dZrO", "uri": "/contracts/8wcNqc4dZrO#defective-processing", "label": "Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)", "score": 28.4168377823, "published": true}], "hash": "dea284d92129aa8b35a4274bb343ba2c", "id": 2}, {"snippet": "Catalent shall, at its option, either (A) replace, at its cost and within [**], any Batch of Defective Product attributable to Catalent Defective Processing (and Client shall be liable to pay for either the rejected Batch(es) or the replacement Batch(es), but not both), or (B) credit within [**] any payments made by Client for such rejected Batch. THE OBLIGATION OF CATALENT TO REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT, IN EACH CASE, WHICH IS ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING, SHALL BE CLIENT\u2019S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, SUBJECT, FOR THE AVOIDANCE OF DOUBT, TO ARTICLE 14.", "size": 3, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [93, 110]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [127, 156]}, {"key": "client-shall", "type": "clause", "offset": [162, 174]}, {"key": "pay-for", "type": "clause", "offset": [188, 195]}, {"key": "by-client", "type": "clause", "offset": [315, 324]}, {"key": "the-obligation", "type": "clause", "offset": [350, 364]}, {"key": "in-accordance-with", "type": "definition", "offset": [406, 424]}, {"key": "the-specifications", "type": "definition", "offset": [425, 443]}, {"key": "each-case", "type": "definition", "offset": [482, 491]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [567, 592]}, {"key": "agreement-for", "type": "clause", "offset": [604, 617]}, {"key": "in-lieu-of", "type": "clause", "offset": [643, 653]}, {"key": "other-warranty", "type": "clause", "offset": [658, 672]}, {"key": "for-the-avoidance-of-doubt", "type": "clause", "offset": [703, 729]}, {"key": "article-14", "type": "definition", "offset": [734, 744]}], "samples": [{"hash": "6g22R9mQyO6", "uri": "/contracts/6g22R9mQyO6#defective-processing", "label": "Commercial Supply Agreement (Lexicon Pharmaceuticals, Inc.)", "score": 28.5811088296, "published": true}, {"hash": "5AbGglvMBb", "uri": "/contracts/5AbGglvMBb#defective-processing", "label": "Commercial Supply Agreement (Lexicon Pharmaceuticals, Inc.)", "score": 28.3374401095, "published": true}], "hash": "826eaf02883b45d9ad85831a24bc8dd5", "id": 3}, {"snippet": "Catalent shall, [***], either (A) [***] or (B) [***]. This shall be Palatin\u2019s sole and exclusive remedy under this Agreement for Defective Product attributable to Catalent Defective Processing, other than as provided in Clause 4.7, 9.5 and 13.1 of this Agreement.", "size": 3, "snippet_links": [{"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [78, 103]}, {"key": "agreement-for", "type": "clause", "offset": [115, 128]}, {"key": "defective-product", "type": "definition", "offset": [129, 146]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [163, 192]}, {"key": "in-clause", "type": "clause", "offset": [217, 226]}], "samples": [{"hash": "dRTGhhNEebn", "uri": "/contracts/dRTGhhNEebn#defective-processing", "label": "Commercial Supply Agreement (Amag Pharmaceuticals, Inc.)", "score": 28.8316221766, "published": true}], "hash": "6d0bcb98f761882065726d5eb98b8255", "id": 4}, {"snippet": "Catalent shall, at Client\u2019s option, either (A) re-Process (or if re\u00ad Processing is not permissible under cGMPs, then replace), at its cost any Batch of Defective Product attributable to Catalent Defective Processing (and Client shall be liable to pay for either the rejected Batch (es) or the replacement Batch (es), but not both), or (B) credit any payments made by Client for such Batch. THE OBLIGATION OF CATALENT TO REPLACE CATALENT DEFECTIVE PROCESSING IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT FOR DEFECTIVE PRODUCT ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING SHALL BE, CLIENT\u2019S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. NOTWITHSTANDING THE FOREGOING, IF THERE ARE MORE THAN [*] OF CATALENT DEFECTIVE PROCESSING IN A [*] PERIOD CLIENT SHALL HAVE SUCH ADDITIONAL RIGHTS AS IN THE EVENT OF A SUPPLY FAILURE UNDER SECTION 4.8 HEREOF FOR ANY SUCH CATALENT DEFECTIVE PROCESSING THAT RESULTS IN A SUPPLY FAILURE. 5.5", "size": 3, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [152, 169]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [186, 215]}, {"key": "client-shall", "type": "clause", "offset": [221, 233]}, {"key": "pay-for", "type": "clause", "offset": [247, 254]}, {"key": "replacement-batch", "type": "definition", "offset": [293, 310]}, {"key": "by-client", "type": "clause", "offset": [364, 373]}, {"key": "the-obligation", "type": "clause", "offset": [390, 404]}, {"key": "in-accordance-with", "type": "definition", "offset": [458, 476]}, {"key": "the-specifications", "type": "definition", "offset": [477, 495]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [617, 642]}, {"key": "agreement-for", "type": "clause", "offset": [654, 667]}, {"key": "in-lieu-of", "type": "clause", "offset": [693, 703]}, {"key": "other-warranty", "type": "clause", "offset": [708, 722]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [744, 773]}, {"key": "additional-rights", "type": "definition", "offset": [874, 891]}, {"key": "in-the-event-of-a", "type": "clause", "offset": [895, 912]}, {"key": "supply-failure", "type": "definition", "offset": [913, 927]}, {"key": "section-48", "type": "clause", "offset": [934, 945]}], "samples": [{"hash": "6zCbPX0pZEL", "uri": "/contracts/6zCbPX0pZEL#defective-processing", "label": "Commercial Supply Agreement", "score": 30.340862423, "published": true}], "hash": "620f7ce5cb4a43b3398308a167156af7", "id": 5}, {"snippet": "In the event of Catalent Defective Processing of any Product Lot, Catalent shall promptly reimburse Client for [ * ], subject to [ * ]. Subject to [ * ], Catalent will, at Client\u2019s option, [ * ].", "size": 2, "snippet_links": [{"key": "in-the-event-of", "type": "definition", "offset": [0, 15]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [16, 45]}, {"key": "product-lot", "type": "definition", "offset": [53, 64]}, {"key": "subject-to", "type": "definition", "offset": [118, 128]}], "samples": [{"hash": "jn1Rla4Ek9I", "uri": "/contracts/jn1Rla4Ek9I#defective-processing", "label": "Commercial Manufacturing Agreement", "score": 31.340862423, "published": true}, {"hash": "likPePUWql2", "uri": "/contracts/likPePUWql2#defective-processing", "label": "Commercial Manufacturing Agreement (Intermune Inc)", "score": 21.1998631075, "published": true}], "hash": "cef67022c4ff139ad551707ebccec533", "id": 6}, {"snippet": "Catalent shall, at its option, either (A) replace at its cost another Batch of Product (as a replacement for any Batch of Defective Product attributable to Catalent Defective Processing) using Client-supplied Materials provided at Client\u2019s cost or (B) credit any payments made by Client for such Batch. EXCEPT IN CASES OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, THE OBLIGATION OF CATALENT TO REPLACE CATALENT DEFECTIVE PROCESSING IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT FOR DEFECTIVE PRODUCT ATTRIBUTABLE TO CATALENT DEFECTIVE PROCESSING SHALL BE CLIENT\u2019S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.", "size": 2, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [122, 139]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [156, 185]}, {"key": "materials-provided", "type": "clause", "offset": [209, 227]}, {"key": "by-client", "type": "clause", "offset": [277, 286]}, {"key": "in-cases-of", "type": "clause", "offset": [310, 321]}, {"key": "gross-negligence-or-willful-misconduct", "type": "definition", "offset": [322, 360]}, {"key": "the-obligation", "type": "clause", "offset": [362, 376]}, {"key": "in-accordance-with", "type": "definition", "offset": [430, 448]}, {"key": "the-specifications", "type": "definition", "offset": [449, 467]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [588, 613]}, {"key": "agreement-for", "type": "clause", "offset": [625, 638]}, {"key": "in-lieu-of", "type": "clause", "offset": [664, 674]}, {"key": "other-warranty", "type": "clause", "offset": [679, 693]}], "samples": [{"hash": "aAJbhLuSHmW", "uri": "/contracts/aAJbhLuSHmW#defective-processing", "label": "Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.)", "score": 24.2470910335, "published": true}, {"hash": "5yNTN9xxOe3", "uri": "/contracts/5yNTN9xxOe3#defective-processing", "label": "Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.)", "score": 24.151266256, "published": true}], "hash": "a4257917d786c0be0d2c1501b1b77045", "id": 7}, {"snippet": "Catalent will, at Client\u2019s option, either replace any Batch of Defective Product, or credit any payments made by Client for such rejected Batch. THE OBLIGATION OF CATALENT TO REPLACE DEFECTIVE PRODUCT OR CREDIT PAYMENTS MADE BY CLIENT FOR DEFECTIVE PRODUCT SHALL BE [*].", "size": 2, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [63, 80]}, {"key": "by-client", "type": "clause", "offset": [110, 119]}, {"key": "the-obligation", "type": "clause", "offset": [145, 159]}], "samples": [{"hash": "gpZcfGa92Xa", "uri": "/contracts/gpZcfGa92Xa#defective-processing", "label": "Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)", "score": 21.0, "published": true}, {"hash": "95Nuhbrxe2u", "uri": "/contracts/95Nuhbrxe2u#defective-processing", "label": "Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)", "score": 21.0, "published": true}], "hash": "48524698a41c56b9151423f72f1a7f53", "id": 8}, {"snippet": "If \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 agrees with Client or if the independent Third-Party laboratory determines that the Batch is Defective Product and the cause of the nonconformity is attributable to Catalent Defective Processing, [***]. Catalent shall at Client\u2019s option, either:\nA. re-Process (if re-Processing is permissible under cGMPs) or replace, at Catalent\u2019s cost, another Batch of Product as a replacement for any such Batch of Defective Product using Client-supplied Materials provided by Client at Client\u2019s cost in sufficient quantities in order for Catalent to complete such re-Processing or replacing (and Client shall be liable to pay for either the Defective Product or the replacement Product, but not both), or B. credit to Client\u2019s account, any payment made by Client for such rejected Batch of Defective Product. THE OBLIGATIONS OF CATALENT SET FORTH IN THIS ARTICLE 5 (TESTING AND RELEASE), AND, AS MAY BE APPLICABLE, SECTION 3.1E (MATERIALS), SECTION 4.1B (SUSPENSION), SECTION 6.3 (SUPPLY FAILURE) AND SECTION 9.8 (RECALL) SHALL BE CLIENT\u2019S SOLE AND EXCLUSIVE REMEDIES UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND ARE IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, IN RESPECT OF DEFECTIVE PRODUCT.", "size": 1, "snippet_links": [{"key": "the-independent", "type": "clause", "offset": [37, 52]}, {"key": "defective-product", "type": "definition", "offset": [105, 122]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [177, 206]}, {"key": "materials-provided-by-client", "type": "clause", "offset": [454, 482]}, {"key": "client-shall", "type": "clause", "offset": [596, 608]}, {"key": "pay-for", "type": "clause", "offset": [622, 629]}, {"key": "replacement-product", "type": "clause", "offset": [666, 685]}, {"key": "to-client", "type": "clause", "offset": [715, 724]}, {"key": "obligations-of", "type": "clause", "offset": [813, 827]}, {"key": "article-5", "type": "clause", "offset": [855, 864]}, {"key": "testing-and-release", "type": "clause", "offset": [866, 885]}, {"key": "section-63", "type": "clause", "offset": [968, 979]}, {"key": "supply-failure", "type": "definition", "offset": [981, 995]}, {"key": "section-98", "type": "clause", "offset": [1001, 1012]}, {"key": "sole-and-exclusive-remedies", "type": "clause", "offset": [1040, 1067]}, {"key": "agreement-for", "type": "clause", "offset": [1079, 1092]}, {"key": "in-lieu-of", "type": "clause", "offset": [1119, 1129]}, {"key": "other-warranty", "type": "clause", "offset": [1134, 1148]}, {"key": "in-respect-of", "type": "clause", "offset": [1170, 1183]}], "samples": [{"hash": "jwgkC6fb3h1", "uri": "/contracts/jwgkC6fb3h1#defective-processing", "label": "Commercial Supply Agreement (Ardelyx, Inc.)", "score": 35.6119096509, "published": true}], "hash": "4126c229325b28a18bd870f14dd4b9f9", "id": 9}, {"snippet": "Catalent shall, at its option, either (A) re-Process at its cost another Batch of Product (as a replacement for any Batch of Defective Product attributable to Catalent Defective Processing) using Client-supplied Materials provided at Client's cost or (B) credit any payments made by Client for such Batch. This shall be Client\u2019s sole and exclusive remedy under this Agreement for Defective Product.", "size": 1, "snippet_links": [{"key": "defective-product", "type": "definition", "offset": [125, 142]}, {"key": "catalent-defective-processing", "type": "definition", "offset": [159, 188]}, {"key": "materials-provided", "type": "clause", "offset": [212, 230]}, {"key": "by-client", "type": "clause", "offset": [280, 289]}, {"key": "sole-and-exclusive-remedy", "type": "clause", "offset": [329, 354]}, {"key": "agreement-for", "type": "clause", "offset": [366, 379]}], "samples": [{"hash": "7IkBnfiho9V", "uri": "/contracts/7IkBnfiho9V#defective-processing", "label": "Commercial Supply Agreement (Minerva Neurosciences, Inc.)", "score": 28.839835729, "published": true}], "hash": "dce0c921a9b7ccf42ec7346f7f7eb50a", "id": 10}], "next_curs": "Cl0SV2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjkLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2Ih1kZWZlY3RpdmUtcHJvY2Vzc2luZyMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"children": [["", ""], ["regulatory-compliance", "Regulatory Compliance"], ["delivery", "Delivery"], ["storage-fees", "Storage Fees"], ["client-and-third-party-expenses", "Client and Third-Party Expenses"]], "size": 28, "title": "Defective Processing", "parents": [["testing-samples-release", "Testing Samples Release"], ["testing-release", "Testing Release"], ["catalent-belgium-s", "Catalent Belgium S"], ["defective-product", "Defective Product"], ["release-defective-product-and-analytical-testing", "Release Defective Product and Analytical Testing"]], "id": "defective-processing", "related": [["defective-products", "Defective Products", "Defective Products"], ["defective-product", "Defective Product", "Defective Product"], ["subprocessing", "Subprocessing", "Subprocessing"], ["grievance-processing", "Grievance Processing", "Grievance Processing"], ["details-of-the-processing", "Details of the Processing", "Details of the Processing"]], "related_snippets": [], "updated": "2025-07-07T12:35:11+00:00"}, "json": true, "cursor": ""}}