{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [0, 15]}, {"key": "changes-to-the", "type": "definition", "offset": [16, 30]}, {"key": "printed-matter", "type": "clause", "offset": [31, 45]}, {"key": "the-parties-shall", "type": "clause", "offset": [47, 64]}, {"key": "unless-otherwise-agreed", "type": "definition", "offset": [128, 151]}, {"key": "obsolete-stock", "type": "definition", "offset": [185, 199]}, {"key": "all-inventory", "type": "clause", "offset": [213, 226]}, {"key": "cost-plus", "type": "definition", "offset": [272, 281]}, {"key": "work-in-process", "type": "definition", "offset": [314, 329]}, {"key": "resulting-from", "type": "definition", "offset": [342, 356]}, {"key": "amendment-to-the", "type": "clause", "offset": [376, 392]}, {"key": "at-any-time", "type": "clause", "offset": [424, 435]}, {"key": "supply-term", "type": "definition", "offset": [447, 458]}, {"key": "by-notice", "type": "clause", "offset": [501, 510]}, {"key": "advance-written-notice", "type": "definition", "offset": [581, 603]}], "size": 2, "samples": [{"hash": "9bANVwT4oOR", "uri": "/contracts/9bANVwT4oOR#labeling-changes", "label": "Contract Manufacturing Agreement (Synova Healthcare Group Inc)", "score": 21.0, "published": true}, {"hash": "6FR8flBeUHz", "uri": "/contracts/6FR8flBeUHz#labeling-changes", "label": "Contract Manufacturing Agreement (Synova Healthcare Group Inc)", "score": 21.0, "published": true}], "snippet": "With respect to changes to the Printed Matter, the Parties shall cooperate in making such changes promptly and Allendale shall, unless otherwise agreed, reimburse NPI for all remaining obsolete stock of Products, all inventory of Printed Matter (at NPI actual acquisition cost plus 15%) and all remaining obsolete work in process of Products resulting from any such change or amendment to the Printed Matter. Allendale may, at any time during the Supply Term, change or amend any item of the labeling by notice hereunder, such change or amendment to be effective after appropriate advance written notice hereof.", "hash": "cdfd315af1da35ef29ed2588b5d39c01", "id": 1}, {"snippet_links": [{"key": "the-cost", "type": "clause", "offset": [51, 59]}, {"key": "the-release", "type": "clause", "offset": [123, 134]}, {"key": "in-this-agreement", "type": "clause", "offset": [145, 162]}, {"key": "after-the-effective", "type": "clause", "offset": [188, 207]}, {"key": "final-judgment-date", "type": "definition", "offset": [208, 227]}, {"key": "packaging-and-labeling", "type": "definition", "offset": [335, 357]}, {"key": "promotional-materials", "type": "clause", "offset": [365, 386]}, {"key": "direct-control", "type": "definition", "offset": [410, 424]}, {"key": "internet-websites", "type": "clause", "offset": [437, 454]}, {"key": "advertising-media", "type": "definition", "offset": [510, 527]}, {"key": "pertaining-to", "type": "definition", "offset": [567, 580]}, {"key": "substantially-similar", "type": "definition", "offset": [637, 658]}, {"key": "health-benefit", "type": "clause", "offset": [665, 679]}, {"key": "for-sale", "type": "clause", "offset": [726, 734]}, {"key": "product-name", "type": "definition", "offset": [755, 767]}, {"key": "joint-support", "type": "clause", "offset": [804, 817]}], "size": 1, "samples": [{"hash": "l1gtn2rGDlO", "uri": "/contracts/l1gtn2rGDlO#labeling-changes", "label": "Settlement Agreement", "score": 22.5838466804, "published": true}], "snippet": "a. 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Hospira shall promptly provide Omeros with a statement of charges for the work to be performed based on its per/hour, per/person rates then in effect and its estimated timeline for implementing the changes. Upon written approval by Omeros, which approval shall be at Omeros\u2019 sole discretion, Hospira shall perform such requested or required labeling and packaging work. 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1733]}, {"key": "the-court", "type": "clause", "offset": [1782, 1791]}], "size": 2, "samples": [{"hash": "lUY5eZhAgHB", "uri": "/contracts/lUY5eZhAgHB#labeling-changes", "label": "Settlement Agreement", "score": 26.4442162902, "published": true}, {"hash": "6WF0W0p6RSx", "uri": "/contracts/6WF0W0p6RSx#labeling-changes", "label": "Settlement Agreement", "score": 25.5358180803, "published": true}], "snippet": "Without admitting wrongdoing or liability and solely to avoid the cost and disruption of further litigation, Perrigo agrees that for a period of twenty four (24) months commencing nine (9) months after the Effective Date, Perrigo will (i) include the language \u201cindividual results may vary\u201d on the labels of the Covered Products and/or any other Perrigo- manufactured glucosamine and/or chondroitin products offered for resale, and (ii) will remove references to \u201crebuilding,\u201d \u201crenewing\u201d \u201cregrowing,\u201d \u201cgrowing,\u201d \u201cadding\u201d or \u201cregenerating\u201d cartilage on the labels of the Covered Products and any other Perrigo-manufactured glucosamine and/or chondroitin products offered for resale.\n(a) The labeling changes described in this Paragraph are not an admission by Defendants regarding the claims in the Litigation or the propriety of statements used or omitted on other versions of the packaging of the Covered Products.\n(b) Perrigo shall have nine (9) months from the Effective Date to begin shipping Covered Products with labels and/or packaging that conform to the terms of the Settlement.\n(c) Neither Perrigo nor any of the Retailers nor any Person in the chain of distribution of the Covered Products shall be required to recall, remove from shelves or pull from distribution or inventory any Covered Products that have been shipped by Perrigo prior to the date commencing nine (9) months after the Effective Date.\n(d) If, after the date of Final Approval, Perrigo becomes aware of additional evidence substantiating that the Covered Products rebuild, renew, regrow, grow, add to or regenerate cartilage, Perrigo may seek the agreement of Settlement Class Counsel to modify Paragraph 10 of the Settlement Agreement. If the Parties are not able to agree, Perrigo may seek relief from the Court.", "hash": "5fa629d140b97fe257aac294a8546df9", "id": 2}, {"snippet_links": [{"key": "product-labeling-and-packaging", "type": "clause", "offset": [67, 97]}, {"key": "written-change-order", "type": "clause", "offset": [117, 137]}, {"key": "to-pfizer", "type": "clause", "offset": [138, 147]}, {"key": "required-modifications", "type": "clause", "offset": [176, 198]}, {"key": "content-of-the", "type": "clause", "offset": [247, 261]}, {"key": "substantial-equivalent", "type": "definition", "offset": [338, 360]}, {"key": "promptly-provide", "type": "clause", "offset": [376, 392]}, {"key": "statement-of", "type": "clause", "offset": [408, 420]}, {"key": "charges-for", "type": "clause", "offset": [431, 442]}, {"key": "work-to-be-performed", "type": "definition", "offset": [447, 467]}, {"key": "based-on", "type": "clause", "offset": [468, 476]}, {"key": "in-effect", "type": "definition", "offset": [513, 522]}, {"key": "estimated-timeline", "type": "clause", "offset": [532, 550]}, {"key": "approval-by", "type": "clause", "offset": [594, 605]}, {"key": "work-performed", "type": "definition", "offset": [774, 788]}, {"key": "in-addition-to", "type": "clause", "offset": [790, 804]}, {"key": "cost-of", "type": "definition", "offset": [832, 839]}, {"key": "quantity-of", "type": "clause", "offset": [1003, 1014]}, {"key": "the-product", "type": "clause", "offset": [1051, 1062]}, {"key": "the-relevant", "type": "clause", "offset": [1104, 1116]}, {"key": "firm-order-period", "type": "definition", "offset": [1117, 1134]}], "size": 2, "samples": [{"hash": "7WRkBpwukno", "uri": "/contracts/7WRkBpwukno#labeling-changes", "label": "Development and Supply Agreement (Trevena Inc)", "score": 29.1779603012, "published": true}], "snippet": "Should \u2587\u2587\u2587\u2587\u2587\u2587\u2587 request or be required to make any modifications to Product labeling and packaging, it shall submit a written change order to Pfizer containing the requested or required modifications, together with any documentation specifying the content of the new labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Pfizer shall promptly provide \u2587\u2587\u2587\u2587\u2587\u2587\u2587 with a statement of estimated charges for the work to be performed based on its per/person, per/hour rates then in effect, and its estimated timeline for implementing the changes. Upon written approval by \u2587\u2587\u2587\u2587\u2587\u2587\u2587, which approval shall not be unreasonably withheld, Pfizer will perform all requested or required labeling and packaging work. \u2587\u2587\u2587\u2587\u2587\u2587\u2587 shall pay Pfizer for the work performed, in addition to reimbursing Pfizer for the cost of any existing labeling and packaging that has become obsolete as a result of such changes; provided, however, that such labeling and packaging shall not exceed the quantity of labeling and packaging required for the Product forecasted by \u2587\u2587\u2587\u2587\u2587\u2587\u2587 for manufacture in the relevant Firm Order Period.", "hash": "1e3b70caed00fec2f68ee12bc471cc69", "id": 3}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "either-party", "type": "definition", "offset": [13, 25]}, {"key": "package-insert", "type": "definition", "offset": [67, 81]}, {"key": "the-party", "type": "clause", "offset": [204, 213]}, {"key": "notify-the", "type": "clause", "offset": [247, 257]}, {"key": "other-party", "type": "definition", "offset": [258, 269]}, {"key": "provide-the", "type": "clause", "offset": [274, 285]}, {"key": "applicable-data", "type": "clause", "offset": [303, 318]}, {"key": "review-and-evaluation", "type": "clause", "offset": [327, 348]}, {"key": "within-thirty", "type": "clause", "offset": [349, 362]}, {"key": "the-parties", "type": "definition", "offset": [397, 408]}, {"key": "in-good-faith", "type": "definition", "offset": [421, 434]}, {"key": "changes-to-the", "type": "definition", "offset": [506, 520]}, {"key": "special-products", "type": "definition", "offset": [557, 573]}, {"key": "major-jurisdictions", "type": "definition", "offset": [577, 596]}, {"key": "each-party", "type": "clause", "offset": [598, 608]}, {"key": "agrees-to", "type": "clause", "offset": [609, 618]}, {"key": "good-faith-discussions", "type": "clause", "offset": [689, 711]}, {"key": "right-to-file", "type": "clause", "offset": [735, 748]}, {"key": "abbvie-territory", "type": "definition", "offset": [940, 956]}], "size": 1, "samples": [{"hash": "awmp19vUX5u", "uri": "/contracts/awmp19vUX5u#labeling-changes", "label": "Special Products Master Agreement (AbbVie Inc.)", "score": 24.0034223135, "published": true}], "snippet": "In the event either Party seeks to change a core label and/or core package insert (e.g., the CCDS, MasterSmPC, core PIL, US PI or its equivalent) for a Special Product due to safety or efficacy concerns, the Party seeking to make the change shall notify the other Party and provide the other Party with applicable data for its review and evaluation within thirty (30) days of compiling such data. The Parties may discuss in good faith and endeavor to agree upon all proposed significant safety or efficacy changes to the labeling and/or package inserts for Special Products in Major Jurisdictions. Each Party agrees to consider all comments of the other in good faith. Notwithstanding any good faith discussions, Abbott shall have the right to file for such labeling change as it reasonably deems appropriate in the Abbott Territory and AbbVie shall have the right to file for such labeling change as it reasonably deems appropriate in the AbbVie Territory, as applicable.", "hash": "5e754a897b29650d3694964b3e34725a", "id": 5}, {"snippet_links": [{"key": "changes-to-the", "type": "definition", "offset": [4, 18]}, {"key": "labeling-and-packaging", "type": "clause", "offset": [19, 41]}, {"key": "in-writing", "type": "clause", "offset": [75, 85]}, {"key": "prior-to-the", "type": "clause", "offset": [118, 130]}, {"key": "implementation-date", "type": "definition", "offset": [139, 158]}, {"key": "required-documentation", "type": "clause", "offset": [177, 199]}, {"key": "the-content", "type": "clause", "offset": [211, 222]}, {"key": "substantial-equivalent", "type": "definition", "offset": [317, 339]}, {"key": "costs-of", "type": "clause", "offset": [395, 403]}, {"key": "cost-of", "type": "definition", "offset": [461, 468]}], "size": 1, "samples": [{"hash": "lhHaTbl4Lr0", "uri": "/contracts/lhHaTbl4Lr0#labeling-changes", "label": "Development and Supply Agreement (Kythera Biopharmaceuticals Inc)", "score": 23.3737166324, "published": true}], "snippet": "Any changes to the labeling and packaging shall be communicated to Hospira in writing at least seventy-five (75) days prior to the desired implementation date together with the required documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Kythera shall reimburse Hospira for Hospira\u2019s actual costs of making any changes under this Section 5.7(b) and for the cost of any labeling that Hospira is unable to use due to such changes.", "hash": "1f404b6efe4a79fdb62b3c23d9e76886", "id": 6}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "either-party", "type": "definition", "offset": [13, 25]}, {"key": "package-insert", "type": "definition", "offset": [57, 71]}, {"key": "the-party", "type": "clause", "offset": [130, 139]}, {"key": "notify-the", "type": "clause", "offset": [173, 183]}, {"key": "other-party", "type": "definition", "offset": [184, 195]}, {"key": "provide-the", "type": "clause", "offset": [200, 211]}, {"key": "applicable-data", "type": "clause", "offset": [229, 244]}, {"key": "review-and-evaluation", "type": "clause", "offset": [253, 274]}, {"key": "the-parties", "type": "definition", "offset": [276, 287]}, {"key": "in-good-faith", "type": "definition", "offset": [300, 313]}, {"key": "changes-to-the", "type": "definition", "offset": [385, 399]}, {"key": "special-products", "type": "definition", "offset": [436, 452]}, {"key": "each-party", "type": "clause", "offset": [454, 464]}, {"key": "agrees-to", "type": "clause", "offset": [465, 474]}, {"key": "good-faith-discussions", "type": "clause", "offset": [545, 567]}, {"key": "right-to-file", "type": "clause", "offset": [591, 604]}, {"key": "abbvie-territory", "type": "definition", "offset": [796, 812]}], "size": 1, "samples": [{"hash": "dLI5DUDanrk", "uri": "/contracts/dLI5DUDanrk#labeling-changes", "label": "Special Products Master Agreement (AbbVie Inc.)", "score": 23.674880219, "published": true}], "snippet": "In the event either Party seeks to change a label and/or package insert for a Special Product due to safety or efficacy concerns, the Party seeking to make the change shall notify the other Party and provide the other Party with applicable data for its review and evaluation. The Parties may discuss in good faith and endeavor to agree upon all proposed significant safety or efficacy changes to the labeling and/or package inserts for Special Products. Each Party agrees to consider all comments of the other in good faith. Notwithstanding any good faith discussions, Abbott shall have the right to file for such labeling change as it reasonably deems appropriate in the Abbott Territory and AbbVie shall have the right to file for such labeling change as it reasonably deems appropriate in the AbbVie Territory, as applicable.", "hash": "7e5d4552b151877a6d6e719c7da50d62", "id": 10}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhlsYWJlbGluZy1jaGFuZ2VzIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Labeling Changes", "size": 19, "parents": [["change-management", "Change Management"], ["product-labeling", "Product Labeling"], ["product-manufacturing", "Product Manufacturing"], ["regulatory-matters", "Regulatory Matters"], ["now-therefore", "NOW, THEREFORE"]], "children": [["", ""], ["fraudulent-filings", "Fraudulent Filings"], ["determination-of-validity", "Determination Of Validity"], ["notice-and-submission-of-claims", "Notice And Submission Of Claims"], ["payment", "Payment"]], "id": "labeling-changes", "related": [["staffing-changes", "Staffing Changes", "Staffing Changes"], ["engineering-changes", "Engineering Changes", "Engineering Changes"], ["conforming-changes", "Conforming Changes", "Conforming Changes"], ["term-sofr-conforming-changes", "Term SOFR Conforming Changes", "Term SOFR Conforming Changes"], ["accounting-changes", "Accounting Changes", "Accounting Changes"]], "related_snippets": [], "updated": "2025-07-07T12:36:18+00:00", "also_ask": ["What negotiation leverage can be gained by controlling labeling change approvals?", "Which essential terms must be included to address regulatory-driven labeling updates?", "What are the main legal risks if labeling changes are delayed or disputed?", "How do labeling change provisions in this contract compare to industry standards?", "What factors most influence a court\u2019s enforcement of labeling change obligations?"], "drafting_tip": "Specify approval procedures for labeling changes to maintain regulatory compliance; define notification timelines to ensure prompt communication; allocate responsibilities to prevent disputes.", "explanation": "The Labeling Changes clause defines the procedures and responsibilities for updating or modifying product labels. Typically, this clause outlines when and how changes to labeling must be communicated between parties, who is responsible for implementing updates, and the approval process required before changes are made. For example, it may specify that regulatory updates or safety information must be promptly reflected on packaging and that both parties must agree on the new label content. The core function of this clause is to ensure that all labeling remains accurate and compliant with applicable regulations, thereby reducing the risk of mislabeling and associated legal or safety issues."}, "json": true, "cursor": ""}}