Common use of FDA Clause in Contracts

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations, except where the failure to be in compliance would not have a Material Adverse Effect. 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.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“"FDA”") under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“"FDCA”") that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company Apricus or any of its Apricus Subsidiaries (each such product, a “"Pharmaceutical Product”"), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company Apricus in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Apricus Material Adverse Effect. There is no pending, completed or, to the Company's Apricus' knowledge, threatened, action (including any lawsuit, arbitration, or legal or ​ administrative or regulatory proceeding, charge, complaint, or investigation) against the Company Apricus or any of its Apricus Subsidiaries, and none of the Company Apricus or any of its Apricus 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company Apricus or any of its Apricus Subsidiaries, (iiiv) enjoins production at any facility of the Company Apricus or any of its Apricus Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company Apricus or any of its Apricus Subsidiaries, or (ivvi) otherwise alleges any violation of any laws, rules or regulations by the Company Apricus or any of its Apricus Subsidiaries, and which, either individually or in the aggregate, would have a Apricus Material Adverse Effect. The properties, business and operations of the Company Apricus have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company Except as set forth on Schedule 4(dd) or as Disclosed in the SEC Documents, Apricus 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 Apricus nor has the CompanyFDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by Apricus.

FDA. As to each product products subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is are manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company Borrowers or any of its their Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company Borrowers in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's Borrowers’ knowledge, threatened, action (including any lawsuit, arbitration, or legal or ​ administrative or regulatory proceeding, charge, complaint, or investigation) against the Company a Borrower or any of its Subsidiaries, and none of the Company or Borrowers nor any of its their Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contest 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company a Borrower or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company a Borrower or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company a Borrower or any of its Subsidiaries, or (ivvi) otherwise alleges any violation of any laws, rules or regulations by the Company a Borrower 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 Borrower 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 Borrowers have 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 a Borrower or any of its Subsidiaries nor has the CompanyFDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by a Borrower or any of its Subsidiaries.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have reasonably be expected to be material to the Company and its Subsidiaries, taken as a Material Adverse Effectwhole. There is no pending, completed or, to the Company's knowledge’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) 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 reasonably be expected to be material to the Company and its Subsidiaries, taken as a Material Adverse Effectwhole. 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 CompanyCompany nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company other than normal investigational product correspondence between the Company and the FDA.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) ), if any, that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There Except as set forth on Schedule 3.1(hh), 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) 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product candidate subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed developed by or on behalf of the Company or any of its Subsidiaries (each such product, a “Pharmaceutical ProductProduct Candidate”), such Pharmaceutical Product Candidate is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company developed in compliance with all applicable requirements under the FDCA and similar analogous laws, rules and regulationsregulations relating to investigational use, non-clinical and clinical development, good manufacturing practices, good laboratory practices, good clinical practices, labeling, record keeping and filing of reports, except where the failure to be in compliance compliance, either individually or in the aggregate, would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, ongoing or pending 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, entity which (i) contests the distribution, manufacturing, packaging, testing, or labeling of any Pharmaceutical Product Candidate, (ii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiii) enjoins production of any Pharmaceutical Product Candidate at any facility of the Company or any of its Subsidiaries, (iiiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivv) otherwise alleges any violation of any applicable laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, 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 compliance 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 developedPharmaceutical Product Candidate, produced or marketed by the Companyif and when approved for marketing.

FDA. As Other than as previously disclosed within the SEC Reports, as to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical ProductMedical Device”), such Pharmaceutical Product Medical Device is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under Section 564 of the FDCA for Emergency Use Authorization (EUA), and similar laws, rules and regulationsthe conditions of authorization of the EUA authorizing the sale of any Company product, except where compliance has been waived by the FDA or the failure to be in compliance would not have a Material Adverse Effect. 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) withdraws any EUA relating to any Medical Device, (ii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiii) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivv) 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 FDAFDA applicable to the manufacture, packing, labeling, testing, distribution, sale and/or marketing of any Medical Device under EUA. The Except as set forth in the SEC Reports, 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There Except as set forth on Schedule 3.1(ff), 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 SubsidiariesCompany, and none of the Company or any of its Subsidiaries has not 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its SubsidiariesCompany, (iiiv) enjoins production at any facility of the Company or any of its SubsidiariesCompany, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its SubsidiariesCompany, or (ivvi) 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“"FDA”") under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“"FDCA”") that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by by, or on behalf of, the Company or any of its Subsidiaries (each such product, a “"Pharmaceutical Product”"), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar all other applicable laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, marketing, billing, distribution, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse EffectChange. 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) 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 EffectChange. 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 FDAFDA and each other governmental entity with jurisdiction over the Company's properties, business and operations. 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company. Neither the Company or any of its Subsidiaries, nor any of their respective employees, officers, directors, or, to the Company's knowledge, agents thereof, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority, except where such agreement would not reasonably be expected to have a Material Adverse Change. Additionally, neither the Company or any of its Subsidiaries nor any of their respective employees, officers, or directors, and, to the knowledge of the Company, agents thereof is or has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical ProductMedical Device”), such Pharmaceutical Product Medical Device is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under Section 564 of the FDCA and similar laws, rules and regulationsfor Emergency Use Authorization, except where compliance has been waived by the FDA or the failure to be in compliance would not have a Material Adverse Effect. 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) contests any Emergency Use Authorization relating to any Medical Device, (ii) withdraws any Emergency Use Authorization relating to any Medical Device, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 FDAFDA applicable to the manufacture, packing, labeling, testing, distribution, sale and/or marketing of any Medical Device under an Emergency Use Authorization. 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a in the United Ststes “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. 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) 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product that is subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder (“FDCA”) and that is being manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Medical Device Product”), such Pharmaceutical Medical Device Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under the FDCA and similar comparable foreign laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, labeling, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's ’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 nor has the Company or any of its Subsidiaries has received any written notice, warning letter or other written communication from the FDA or any other governmental entity, which entity that (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 Medical Device Product, (ii) imposes a clinical hold on any clinical investigation involving a Medical Device Product being conducted or sponsored 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 the FDCA or any comparable foreign 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 sale or use in the United States of any product proposed to be developed, produced or marketed Medical Device Product being developed by the Company.

FDA. As Except as set forth on Schedule 3.1(hh), as to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There Except as set forth on Schedule 3.1(hh), 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) 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, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 Except as set forth on Schedule 3.1(hh), 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.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in the United States in compliance with all applicable requirements under FDCA and similar laws, rules and regulationsregulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's ’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 except as disclosed in the Registration Statement, the Base Prospectus, the Prospectus Supplement, the Prospectus or the Incorporated Documents, 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 Pharmaceutical 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 Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiv) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivvi) 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 FDAFDA for such operations being conducted in the United States. 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As Other than as previously disclosed within the SEC Reports, as to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical ProductMedical Device”), such Pharmaceutical Product Medical Device is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under Section 564 of the FDCA for Emergency Use Authorization (EUA), and similar laws, rules and regulationsthe conditions of authorization of the EUA authorizing the sale of any Company product, except where compliance has been waived by the FDA or the failure to be in compliance would not have a Material Adverse Effect. 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) withdraws any Emergency Use Authorization relating to any Medical Device, (ii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iiiii) enjoins production at any facility of the Company or any of its Subsidiaries, (iiiiv) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (ivv) 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 FDAFDA applicable to the manufacture, packing, labeling, testing, distribution, sale and/or marketing of any Medical Device under an Emergency Use Authorization. The Except as set forth in the SEC Reports, 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 nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's ’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.