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The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. 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There is no pending, completed or, to the Company\u2019s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. 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There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (ii) enjoins production at any facility of the Company or any of its Subsidiaries, (iii) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (iv) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company.", "hash": "fc21d7fd02f8d7517319a0ea0ab17f75", "id": 7}, {"samples": [{"hash": "gKTDDmCNp69", "uri": "/contracts/gKTDDmCNp69#fda", "label": "Supply and Manufacturing Agreement", "score": 31.3408622742, "published": true}, {"hash": "7pZxjMS9hqR", "uri": "/contracts/7pZxjMS9hqR#fda", "label": "Supply and Manufacturing Agreement (Quanterix Corp)", "score": 28.8548946381, "published": true}, {"hash": "lWofy4oBivX", "uri": "/contracts/lWofy4oBivX#fda", "label": "Supply and Manufacturing Agreement (Quanterix Corp)", "score": 28.6249141693, "published": true}], "snippet_links": [{"key": "the-united-states", "type": "definition", "offset": [28, 45]}, {"key": "food-and-drug-administration", "type": "definition", "offset": [46, 74]}, {"key": "successor-agency", "type": "definition", "offset": 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Company\u2019s Knowledge, there is no pending, completed or threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the U.S. Food and Drug Administration (\u201cFDA\u201d) or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any product subject to the jurisdiction of the FDA under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a \u201cPharmaceutical Product\u201d), (ii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iii) enjoins production at any facility of the Company or any of its Subsidiaries, (iv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (v) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The Company has not been informed in writing by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company.", "hash": "c1afc7e98a4624755761e1bc7c0d41e0", "id": 10}], "next_curs": "CkwSRmoVc35sYXdpbnNpZGVyY29udHJhY3RzcigLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IgxmZGEjMDAwMDAwMGEMogECZW4YACAA", "clause": {"title": "FDA", "size": 3462, "parents": [["representations-and-warranties-of-the-company", "Representations and Warranties of the Company"], ["representations-and-warranties", "Representations and Warranties"], ["sec-reports-financial-statements", "SEC Reports; Financial Statements"], ["definitions", "Definitions"], ["representations-warranties-and-covenants-of-the-company", "Representations, Warranties and Covenants of the Company"]], "children": [["regulatory-and-other-inquiries", "Regulatory and other Inquiries"], ["side-effects", "Side Effects"], ["product-recall", "Product Recall"], ["", ""], ["liquidated-damages-for-failure-to-timely-deliver", "Liquidated Damages for failure to Timely Deliver"]], "id": "fda", "related": [["regulatory-authorities", "Regulatory Authorities", "Regulatory Authorities"], ["alcohol-and-drug-testing", "Alcohol and Drug Testing", "Alcohol and Drug Testing"], ["regulatory-authority", "Regulatory Authority", "Regulatory Authority"], ["regulatory-approval", "Regulatory Approval", "Regulatory Approval"], ["regulatory-authorizations", "Regulatory Authorizations", "Regulatory Authorizations"]], "related_snippets": [], "updated": "2026-04-22T04:28:35+00:00", "also_ask": ["What are the minimum FDA compliance requirements that must be explicitly stated in this clause?", "How can this clause be leveraged to allocate regulatory risk between the parties?", "What are the most common pitfalls in drafting FDA-related clauses that could render them unenforceable?", "How does this clause compare to standard FDA provisions in similar industry contracts?", "What evidence is typically required in court to prove breach of an FDA compliance clause?"], "drafting_tip": "Specify FDA compliance requirements to ensure regulatory adherence; define reporting obligations to clarify responsibilities; reference applicable FDA regulations to avoid ambiguity.", "explanation": "The FDA clause defines the obligations and requirements related to compliance with the U.S. Food and Drug Administration's regulations. It typically applies to products that are subject to FDA oversight, such as pharmaceuticals, medical devices, or food items, and may require parties to ensure that all necessary approvals, registrations, or clearances are obtained before products are marketed or distributed. This clause serves to ensure that all parties adhere to applicable legal and regulatory standards, thereby reducing the risk of non-compliance and potential legal or financial penalties."}, "json": true, "cursor": ""}}