Regulatory and Product Notices Clause Samples
The "Regulatory and Product Notices" clause requires parties to inform each other about relevant regulatory requirements or product-related information that may affect their obligations under the agreement. This typically involves providing timely updates about changes in laws, safety standards, or compliance obligations that impact the manufacture, sale, or distribution of products. By mandating such notifications, the clause ensures both parties remain aware of legal and regulatory developments, thereby reducing the risk of non-compliance and facilitating smooth business operations.
Regulatory and Product Notices. The Borrower shall promptly (but in any event within three (3) days) after the receipt or occurrence thereof notify Agent of:
(i) any written notice received by Borrower or its Subsidiaries alleging potential or actual violations of any Public Health Law by Borrower or its Subsidiaries,
(ii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registration (including, but not limited to, by the issuance of a clinical hold),
(iii) any written notice that Borrower or its Subsidiaries has become subject to any Regulatory Action,
(iv) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of Borrower or its Subsidiaries or its or their authorized officers,
(v) 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(vi) any written notice that any product of Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking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,
(vii) 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 (i) through (viii) above, where such action would not reasonably be expected to have, either individually or in the aggregate, Material Regulatory Liabilities.
Regulatory and Product Notices. Each Loan Party shall promptly (but in any event within ten (10) Business Days) after the receipt or occurrence thereof notify Administrative Agent of:
(i) any written notice received by the Company or its Subsidiaries alleging potential or actual material violations of any Public Health Law by the Company or its Subsidiaries,
(ii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registration (including, but not limited to, by the issuance of a clinical hold),
(iii) any written notice that the Company or its Subsidiaries has become subject to any Regulatory Action (other than any inspection or investigation in the ordinary course of business), CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION (iv) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of the Company or its Subsidiaries or its or their Authorized Officers,
Regulatory and Product Notices. Borrower shall within three (3) Business Days after the receipt or occurrence thereof notify Agent of:
Regulatory and Product Notices. Each Loan Party shall promptly (but in any event within ten (10) Business Days) after the receipt or occurrence thereof notify Administrative Agent of:
(i) any written notice received by the Company or its Subsidiaries alleging potential or actual material violations of any Public Health Law by the Company or its Subsidiaries,
(ii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registration (including, but not limited to, by the issuance of a clinical hold),
(iii) any written notice that the Company or its Subsidiaries has become subject to any Regulatory Action (other than any inspection or investigation in the ordinary course of business), (iv) the exclusion or debarment from any governmental healthcare program or debarment or disqualification by FDA (or international equivalent) of the Company or its Subsidiaries or its or their Authorized Officers,
Regulatory and Product Notices. Each Loan Party shall promptly (but in any event within [**]) after the receipt or occurrence thereof notify Administrative Agent of: (i) any written notice received by Borrower or its Subsidiaries alleging potential or actual material violations of any Public Health 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, (ii) any written notice that the FDA (or international equivalent) is limiting, suspending or revoking any Registration (including, but not limited to, by the issuance of a clinical hold order),
Regulatory and Product Notices. Borrower shall promptly (but in any event within three (3) 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 from the FDA 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 from a governmental authority that Borrower or its Subsidiaries has become subject to any Regulatory Action, (d) any written notice from the FDA indicating 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 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 or any other jurisdiction seeking the withdrawal, recall, suspension, import
Regulatory and Product Notices. The Borrower shall promptly (but in any event within three (3) 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 applicable FDA Laws or applicable 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,
Regulatory and Product Notices. The Borrower shall promptly (but in any event within three (3) 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 applicable FDA Laws or applicable 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,