Common use of Regulatory and Product Notices Clause in Contracts

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Agent of: (a) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Health Care Program Laws by Borrower or its Subsidiaries; (b) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations (including, but not limited to, the issuance of a clinical hold); (c) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries; (e) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or (f) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; except, in each case of (a) through (f) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five three (53) Business Daysdays) after the receipt or occurrence thereof notify Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their authorized officers, (ev) any notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or, (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , or (viii) considering or implementing any other such regulatory action, except, in each case of (ai) through (fviii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five three (53) Business Days) after the receipt or occurrence thereof notify Agent of: (a) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Health Care Program Laws by Borrower or its Subsidiaries;, (b) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations (including, but not limited to, the issuance of a clinical hold);, (c) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;, (e) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; , or (f) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , except, in each case of (a) through (f) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Agent of: (a) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (b) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (c) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their executive-level officers, (e) any written notice that a Borrower or any Subsidiary is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (f) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or, (fg) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products to a material extent of Borrower and its Subsidiaries under any such Registration; , or (h) except, in each case of (a) through (fg) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five ten (510) Business Days) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower the Company or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower the Company or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that Borrower the Company or its Subsidiaries has become subject to any Regulatory Action;Action (other than any inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower the Company or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that the Company or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (vi) any written notice that any product of Borrower the Company or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower the Company or its Subsidiaries; , or (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower the Company and its Subsidiaries under any such Registration; , except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.; provided, however, that with respect to any occurrence in clauses (i) through (vii) above that could, with notice or the passage of time, or both, lead to a Default or Event of Default under Section 8.1(o) of this Agreement, each Loan Party shall promptly (but in any event within three (3) Business Days of Administrative Agent’s request) provide to Administrative Agent copies of all communications with FDA and all other documentation and information in such Loan Party’s possession, custody or control reasonably requested by Administrative Agent relating to such notice or change and the events that led up to it (subject to suitable confidentiality restrictions);

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five three (53) Business Daysdays) after the receipt or occurrence thereof notify Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their authorized officers, (ev) any notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the 61 US-DOCS\126945775.5 withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or, (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , or (viii) considering or implementing any other such regulatory action, except, in each case of (ai) through (fviii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days[***]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by the Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by the Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that the Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of the Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that the Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws in any material respect, (vi) any written notice that any material product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against the Borrower or its Subsidiaries; , or (fvii) narrowing limiting or otherwise limiting adversely changing the scope of marketing authorization or the labeling of the products of the Borrower and its Subsidiaries under any such Registration; , except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.; provided, however, that with respect to any occurrence in clauses (i) through (vii) above that could, with notice or the passage of time, or both, lead to a Default or an Event of Default under Section 8.1(o) of this Agreement, each Loan Party shall promptly (but in any event within [***] of Administrative Agent’s request) provide to Administrative Agent copies of all communications with FDA and all other documentation and information in such Loan Party’s possession, custody or control reasonably requested by Administrative Agent relating to such notice or change and the events that led up to it (subject to suitable confidentiality restrictions);

Regulatory and Product Notices. The Borrower shall promptly within three (but in any event within five (53) Business Days) Days after the receipt or occurrence thereof notify Agent of: (a) any written notice from a governmental authority received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries; (b) any written notice from a governmental authority that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold); ; (c) any written notice from a governmental authority that Borrower or its Subsidiaries has become subject to any Regulatory Action; ; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries; Subsidiaries or its or their authorized officers; (e) any notice from a governmental authority that Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws; (f) any written notice from a governmental authority that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States of America or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or or (fg) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; except, it being understood that the Approval Milestone is contingent on a label claim that is generally consistent with or generally as favorable as what Borrower sought for one dose of Resmetirom in each case of its New Drug Application (a) through (f) above, where such action would not reasonably be expected to have, either individually or as determined by Agent in the aggregate, any Material Regulatory Liabilitiesits reasonable discretion).

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days[***]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws Public Health Law or Federal Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalentequivalent [***]) or other Governmental Authority [***] is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any routine inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program Federal Health Care Program or debarment or disqualification by FDA (or international equivalentequivalent [***]) of Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Public Health Law or Health Care Program Laws, (vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; . except, in each case of (ai) through (fiii) and (v) through (viii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.;

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations (including, but not limited to, the issuance of a clinical hold);Registration, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare health care program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice addressed to Borrower or any Subsidiary that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, in each case, which could reasonably be expected to result in a Material Adverse Effect, (vi) any written notice that any product Product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other by a Governmental Authority having appropriate jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product or Products are pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing changing the market classification or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; Registration in a manner materially adverse to Borrower and its Subsidiaries, except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.;

Regulatory and Product Notices. The Borrower shall promptly within three (but in any event within five (53) Business Days) Days after the receipt or occurrence thereof notify Agent of: (a) any written notice from a Governmental Authority received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries; (b) any written notice from a Governmental Authority that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold); (c) any written notice from a Governmental Authority that Borrower or its Subsidiaries has become subject to any Regulatory Action; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its SubsidiariesSubsidiaries or its or their authorized officers; (e) any notice from a Governmental Authority that Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws; (f) any written notice from a Governmental Authority that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States of America or any other jurisdiction seeking the seizure, withdrawal, recall, suspension, import detention, or seizure suspension of manufacturing, of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or (fg) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; . except, in each case of (a) through (fg) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days[***]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by the Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by the Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that the Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of the Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that the Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws in any material respect, (vi) any written notice that any material product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against the Borrower or its Subsidiaries; , or (fvii) narrowing limiting or otherwise limiting adversely changing the scope of marketing authorization or the labeling of the products of the Borrower and its Subsidiaries under any such Registration; , except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.; provided, however, that with respect to any occurrence in clauses (i) through (vii) above that could, with notice or the passage of time, or both, lead to a Default or an Event of Default under Section 8.1(o) of this Agreement, each Loan Party shall promptly (but in any event within [***] of Administrative Agent’s request) provide to Administrative Agent copies of all communications with FDA and all other documentation and information in such Loan Party’s possession, custody or control reasonably requested by Administrative Agent relating to such notice or change and the events that led up to it (subject to suitable confidentiality restrictions); |

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five three (53) Business Daysdays) after the receipt or occurrence thereof notify Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, ​ ​ (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their authorized officers, (ev) any notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or, (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , or (viii) considering or implementing any other such regulatory action, except, in each case of (ai) through (fviii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days[***]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws Public Health Law or Federal Health Care Program Laws Law, in each case, in any Material Jurisdiction or any Specified Jurisdiction by Borrower or its Subsidiaries;, (bii) any written notice received by Borrower or its Subsidiaries that the FDA (or international equivalent) or other Governmental Authority in any Material Jurisdiction or any Specified Jurisdiction is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice received by Borrower or its Subsidiaries that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any routine inspection or investigation in the ordinary course of business) in any Material Jurisdiction or any Specified Jurisdiction, (div) the exclusion or debarment from any governmental healthcare program Federal Health Care Program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or any officer, director, managing employee or agent (as those terms are defined in 42 C.F.R. § 1001.2) thereof or any employee or contractor thereof, (ev) any written notice received by Borrower or its Subsidiaries that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements related to Product Intellectual Property Rights or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Public Health Law or Health Care Laws, in each case, in any Material Jurisdiction or any Specified Jurisdiction, (vi) any written notice received by Borrower or its Subsidiaries that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States any Material Jurisdiction or any other jurisdiction Specified Jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing or otherwise limiting of the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , in each case, in any Material Jurisdiction or any Specified Jurisdiction, except, in each case of (ai) through (fiii) and (v) through (vii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.; provided, however, that with respect to any occurrence in clauses (i) through (vii) above that would, with notice or the passage of time, or both, lead to a Default or an Event of Default under Section 8.1(o) of this Agreement, each Loan Party shall promptly (but in any event within [***] of Administrative Agent’s request) provide to Administrative Agent copies of all communications with FDA and all other documentation and information in such Loan Party’s possession, custody or control reasonably requested by Administrative Agent relating to such notice or change and the events that led up to it (subject to suitable confidentiality restrictions);

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly [*] (but in any event within five (5) Business Days[*]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws Public Health Law or Federal Health Care Program Laws Law by Borrower or its Subsidiaries;, (bii) any written notice that the FDA (or international equivalent) or other Governmental Authority is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any routine inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program Federal Health Care Program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that a Borrower or any Subsidiary, or to the knowledge of the Borrower, any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Public Health Law or Health Care Program Laws, (vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are is pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; . except, in each case of (ai) through (fiii) and (v) through (vii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.;

Regulatory and Product Notices. The Borrower shall promptly within three (but in any event within five (53) Business Days) Days after the receipt or occurrence thereof notify Agent of: (a) any written notice from a governmental authority received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries; (b) any written notice from a governmental authority that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold); (c) any written notice from a governmental authority that Borrower or its Subsidiaries has become subject to any Regulatory Action; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its SubsidiariesSubsidiaries or its or their authorized officers; (e) any notice from a governmental authority that Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws; (f) any written notice from a governmental authority that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States of America or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or (fg) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; , it being understood that the Approval Milestone is contingent on a label claim that is generally consistent with or generally as favorable as what Xxxxxxxx sought for one dose of Resmetirom in its New Drug Application (as determined by Agent in its reasonable discretion). except, in each case of (a) through (fg) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five four (54) Business Days) after the receipt or occurrence thereof notify Agent of: (a) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries; (b) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold); (c) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its SubsidiariesSubsidiaries or its or their authorized officers; (e) any written notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws; (f) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States of America or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or; (fg) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; or (h) considering or implementing any other such Regulatory Action; except, in each case of (a) through (fh) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities. Notwithstanding the foregoing, documents required to be delivered under this Section 7.16 (to the extent any such documents are included in materials otherwise filed with the Securities and Exchange Commission) may be delivered electronically and, if so delivered, shall be deemed to have been delivered on the date on which Borrower emails a link thereto to Agent; provided that if such link is incomplete or incorrect in any respect, then such delivery shall be deemed not to have been made for purposes hereof.

Regulatory and Product Notices. The Borrower shall promptly within three (but in any event within five (53) Business Days) Days after the receipt or occurrence thereof notify Agent of: (a) any written notice from a governmental authority received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries; (b) any written notice from a governmental authority that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);; ny-2659060 (c) any written notice from a governmental authority that Borrower or its Subsidiaries has become subject to any Regulatory Action; (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its SubsidiariesSubsidiaries or its or their authorized officers; (e) any notice from a governmental authority that Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any material agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws; (f) any written notice from a governmental authority that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States of America or any other jurisdiction seeking the seizure, withdrawal, recall, suspension, import detention, or seizure suspension of manufacturing, of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; or (fg) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; . except, in each case of (a) through (fg) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days[**]) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;, or any written notice from the FTC alleging potential unfair or anticompetitive business practices by Borrower or any of its Subsidiaries, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical holdhold order);, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any routine inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements or Material Contracts), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (vi) any written notice that any product Product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing or otherwise limiting any change in the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.;

Regulatory and Product Notices. The Borrower Each Loan Party shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Administrative Agent of: (ai) any written notice received by Borrower or its Subsidiaries from a governmental authority alleging potential or actual material violations of any FDA Laws or Federal Public Health Care Program Laws Law by Borrower or its Subsidiaries;Subsidiaries by any Governmental Authority, (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations (including, but not limited to, the issuance of a clinical hold);Registration, (ciii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;Action (other than any inspection or investigation in the ordinary course of business), (div) the exclusion or debarment from any governmental healthcare health care program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their Authorized Officers, (ev) any written notice addressed to Borrower or any Subsidiary that a Borrower or any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under the Product Agreements), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, in each case, which could reasonably be expected to result in a Material Adverse Effect, (vi) any written notice that any product Product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other by a Governmental Authority having appropriate jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product or Products are pending or threatened in writing against Borrower or its Subsidiaries; , or (fvii) narrowing changing the market classification or otherwise limiting the scope of marketing authorization or the labeling of the products Products of Borrower and its Subsidiaries under any such Registration; Registration in a manner materially adverse to Borrower and its Subsidiaries,[reserved], except, in each case of (ai) through (fvii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities;.

Regulatory and Product Notices. The Borrower shall promptly Promptly (but in any event within five ten (510) Business Days) after the receipt or occurrence thereof notify Administrative Agent of: , and provide to Administrative Agent a complete and correct copy of all relevant documentation with respect to, (ai) any written notice received by Borrower Company or its Subsidiaries from a governmental authority any Governmental Authority alleging potential or actual violations of any FDA Laws Law, Federal Healthcare Program Law or Federal Public Health Care Program Laws Law by Borrower Company or its Subsidiaries; , (bii) any written notice received by the Company or its Subsidiaries that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration, (including, but not limited to, the issuance of a clinical hold); (ciii) any written notice that Borrower received by Company or its Subsidiaries that the Company or any of its Subsidiaries or the Product has become subject to any Regulatory Action; , (div) any settlement, consent or similar agreement with the FDA or other Governmental Authority (including foreign) regarding the Product to which the Company or its Subsidiaries is a party, (v) any written notice received by the Company of the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower Company or its Subsidiaries; Subsidiaries or its or their Authorized Officers, employees, licensees, vendors, or other commercial partners that directly participate in the development or Commercialization of the Product, (evi) any written notice that any product of Borrower received by the Company or its Subsidiaries that any Product has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower Company or its Subsidiaries; or , (fvii) narrowing any written notice received by the Company of any change to the market classification or otherwise limiting the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries Product under any such Registration; , (viii) any written notice received by the Company that the FDA (or its international equivalent) is considering any of the foregoing if actually known by the Company or (ix) any Authorized Officer of Company becomes aware of the occurrence of any of the events of the type that would trigger the notices described set forth in (ii), (v), (vi) or (vii) above, except, in each case of (ai) through (fix) above, where such action would not reasonably be expected to haveadversely affect the rights, either individually remedies and benefits available to, or conferred upon, Administrative Agent and any Lender or any other Secured Party under any Loan Document in the aggregate, any Material Regulatory Liabilities.material respect;

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Agent of: (ai) any written notice received by the Borrower or its Subsidiaries from a governmental authority alleging potential or actual violations of any FDA Laws or Federal Health Care Program Laws by Borrower or its Subsidiaries;the Borrower (bii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations (including, but not limited to, the issuance of a clinical hold); (ciii) any written notice that the Borrower or its Subsidiaries has become subject to any Regulatory Action; (div) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiariesthe Borrower; (ev) any written notice that any product of Borrower or its Subsidiaries Product has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiariesthe Borrower; or (fvi) narrowing or otherwise limiting the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries Products under any such Registration; except, in each case of subclauses (ai) through (fvi) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.

Regulatory and Product Notices. The Borrower shall promptly (but in any event within five (5) Business Days) after the receipt or occurrence thereof notify Agent of: (a) any written notice received by Borrower or its Subsidiaries from a governmental authority Governmental Authority alleging potential or actual violations of any FDA Laws or Federal applicable Public Health Care Program Laws Law by Borrower or its Subsidiaries;, (b) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registrations Registration (including, but not limited to, by the issuance of a clinical hold);, (c) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action;, (d) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries;Subsidiaries or its or their C-suite officers, (e) any written notice that any product of a Borrower or its Subsidiaries any Subsidiary, or any of their licensees or sublicensees (including licensees or sublicensees under any Material Agreement), is being investigated or is the subject of any allegation of potential or actual violations of any Federal Health Care Program Laws, (f) any written notice that any Borrower Product has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any Borrower Product are pending or threatened in writing against Borrower or its Subsidiaries; , or (fg) narrowing or otherwise limiting changing the scope of marketing authorization or the labeling of the products of Borrower and its Subsidiaries under any such Registration; , except, in each case of (a) through (fg) above, where such action would not reasonably be expected to have, either individually or in the aggregate, any Material Regulatory Liabilities.