Common use of Regulatory Covenants Clause in Contracts

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).

Appears in 5 contracts

Samples: Credit, Security and Guaranty Agreement (Revolving Loan) (Xtant Medical Holdings, Inc.), Credit, Security and Guaranty Agreement (Term Loan) (Xtant Medical Holdings, Inc.), Credit, Security and Guaranty Agreement (Term Loan) (Xtant Medical Holdings, Inc.)

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Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material necessary Permit and other material rights from, and have made all material necessary declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties Borrowers shall ensure that all such necessary Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (cb) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit PartyBorrower. (dc) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by applicable Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall respect), except where failure to do so would not remain open or unsettled)reasonably be expected to have a Material Adverse Effect.

Appears in 2 contracts

Samples: Credit and Security Agreement (Term Loan) (Treace Medical Concepts, Inc.), Credit and Security Agreement (Treace Medical Concepts, Inc.)

Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit, in each case, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Credit Parties Borrowers shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties Borrowers will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Credit Parties Borrowers as it is conducted on the Closing Date, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit Party. (d) Except Borrower, except where the failure to do so would not reasonably be expected to result in have a Material Adverse Effect, Credit Parties . (d) Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by Healthcare Laws (which reports will except where the failure to do so would not reasonably be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled)expected to have a Material Adverse Effect.

Appears in 2 contracts

Samples: Credit and Security Agreement (Revolving Loan) (Radius Health, Inc.), Credit and Security Agreement (Term Loan) (Radius Health, Inc.)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Credit Parties determine to sell or market any new Product commercially, Credit Parties shall deliver, together with delivery of the next quarterly Compliance Certificate, an updated Schedule 4.17 to the Disclosure Letter reflecting updates related to such determination (which shall also include a brief description of such Product).

Appears in 2 contracts

Samples: Credit, Security and Guaranty Agreement (Term Loan) (Cerus Corp), Credit, Security and Guaranty Agreement (Cerus Corp)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party.. MidCap / Cerus / A&R Credit, Security and Guaranty Agreement (Revolving Loan) (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Credit Parties determine to sell or market any new Product commercially, Credit Parties shall deliver, together with delivery of the next quarterly Compliance Certificate, an updated Schedule 4.17 to the Disclosure Letter reflecting updates related to such determination (which shall also include a brief description of such Product).

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (Revolving Loan) (Cerus Corp)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material necessary Permit and other material rights from, and have made all material necessary declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Subsidiaries thereof and Credit Parties shall take take, and cause each of their Subsidiaries to take, such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure ensure, and cause each of their Subsidiaries to ensure, that all such necessary Permits are valid and in full force and effect and Credit Parties and their Subsidiaries are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (cb) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (dc) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will, and will cause their Subsidiaries to, timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by applicable Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).. MidCap / Viewray / Credit, Security and Guaranty Agreement

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (ViewRay, Inc.)

Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties Borrower shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such PermitsPermits in all material respects. (b) Credit Parties Borrowers will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Credit Parties Borrowers as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse EffectDate in all material respects. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained obtain and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit PartyBorrower. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Borrowers determine to manufacture, sell, develop, test or market any new Product or obtain a material Regulatory Required Permit, Borrowers shall deliver written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required Permit) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 4.17 (and copies of such Permits as Agent may request) reflecting updates related to such determination. MidCap / Sientra / A&R Credit and Security Agreement (Term) \DC - 036639/000049 - 14173176 v11

Appears in 1 contract

Samples: Credit and Security Agreement (Term Loan) (Sientra, Inc.)

Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties Borrower shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such PermitsPermits in all material respects. (b) Credit Parties Borrower will, and will cause each Subsidiary to, maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Credit Parties Borrowers and such Subsidiaries as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse EffectDate in all material respects. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower or any Subsidiary, each Credit Party Borrower shall have obtained comply, and comply shall cause such Subsidiaries to comply, in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by Borrower or such Credit Party Subsidiary as such activities are at any such time being conducted by Borrower or such Credit PartySubsidiary. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse EffectBorrower will, Credit Parties and will cause each of its Subsidiaries to, timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Borrower or any Subsidiary determines to manufacture, sell, develop, test or market any new Product or initiate the process to seek any material Regulatory Required Permit other than as contemplated by the Purchase Agreement, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required Permit) and, together with delivery of the next Compliance Certificate delivered with respect to the last month of a fiscal quarter, shall provide an updated Schedule 4.17 (and copies of such Permits as Agent may request) reflecting updates related to such determination.

Appears in 1 contract

Samples: Credit and Security Agreement (PTC Therapeutics, Inc.)

Regulatory Covenants. (a) Credit Parties Each Borrower shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals Authorities necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit, in each case, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. Credit Parties Borrowers shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. (cb) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit Party. (d) Except Borrower, except where the failure to do so would not reasonably be expected to result in have a Material Adverse Effect, Credit Parties . (c) Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by Healthcare Laws (which reports will except where the failure to do so would not reasonably be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled)expected to have a Material Adverse Effect.

Appears in 1 contract

Samples: Credit and Security Agreement (Term Loan) (Radius Health, Inc.)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports MidCap / Cerus / Credit, Security and Guaranty Agreement (Term Loan) \DC - 036639/000093 - 13934788 v5 202344533 v5 required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Credit Parties determine to sell or market any new Product commercially, Credit Parties shall deliver, together with delivery of the next quarterly Compliance Certificate, an updated Schedule 4.17 to the Disclosure Letter reflecting updates related to such determination (which shall also include a brief description of such Product).

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (Term Loan) (Cerus Corp)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Parties’ business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).. MidCap / Xtant / A&R Credit, Security and Guaranty Agreement (Revolving Loan)

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (Revolving Loan) (Xtant Medical Holdings, Inc.)

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Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Parties’ business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (Term Loan) (Xtant Medical Holdings, Inc.)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Credit Parties shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure that all such Permits are valid and in full force and effect and Credit Parties are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties Parties; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit Party, each Credit Party shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party as such activities are at any such time being conducted by such Credit Party. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).

Appears in 1 contract

Samples: Credit and Security Agreement (Conformis Inc)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material necessary Permit and other material rights from, and have made all material necessary declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Subsidiaries thereof and Credit Parties shall take take, and MidCap / Apyx Medical / Credit, Security and Guaranty Agreement cause each of their Subsidiaries to take, such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure ensure, and cause each of their Subsidiaries to ensure, that all such necessary Permits are valid and in full force and effect and Credit Parties and their Subsidiaries are in material compliance with the terms and conditions of all such material Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyParty or any Subsidiary thereof, each Credit Party shall have, and shall have caused each of its Subsidiaries to have, obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party or its Subsidiaries as such activities are at any such time being conducted by such Credit PartyParty or its Subsidiaries. (dc) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will, and will cause their Subsidiaries to, timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by applicable Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).

Appears in 1 contract

Samples: Credit, Security and Guaranty Agreement (Apyx Medical Corp)

Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties Borrower shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such PermitsPermits in all material respects. (b) Credit Parties Borrowers will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Credit Parties Borrowers as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse EffectDate in all material respects. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained obtain and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit PartyBorrower. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Borrowers determine to manufacture, sell, develop, test or market any new Product or obtain a material Regulatory Required Permit, Borrowers shall deliver written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required Permit) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 4.17 (and copies of such Permits as Agent may request) reflecting updates related to such determination.

Appears in 1 contract

Samples: Credit and Security Agreement (Sientra, Inc.)

Regulatory Covenants. (a) Credit Parties Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other material rights from, and have made all material declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party Borrower and Credit Parties Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties Borrower shall ensure that all such Permits are valid and in full force and effect and Credit Parties Borrowers are in material compliance with the terms and conditions of all such Permits.. MidCap / HTG / Credit and Security Agreement (Term Loan) \\DC - 036639/000001 - 12092479 (b) Credit Parties Borrowers will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; Borrowers’ business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties Borrowers as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyBorrower, each Credit Party Borrower shall have obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party Borrower as such activities are at any such time being conducted by such Credit PartyBorrower. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, Permit renewals and reports required by Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled). (e) If, after the Closing Date, Borrowers determine to sell or market any new Product commercially (excluding for the avoidance of doubt any revisions to the Borrower’s existing assays), Borrowers shall deliver, together with delivery of the next Compliance Certificate, an updated Schedule 4.17 to the Disclosure Letter reflecting updates related to such determination (which shall also include a brief description of such Product).

Appears in 1 contract

Samples: Credit and Security Agreement (Term Loan) (HTG Molecular Diagnostics, Inc)

Regulatory Covenants. (a) Credit Parties shall have, and shall ensure that it and each of its Subsidiaries has, each material necessary Permit and other material rights from, and have made all material necessary declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Credit Party and Subsidiaries thereof and Credit Parties shall take take, and cause each of their Subsidiaries to take, such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Credit Parties shall ensure ensure, and cause each of their Subsidiaries to ensure, that all such necessary Permits are valid and in full force and effect and Credit Parties and their Subsidiaries are in material compliance with the terms and conditions of all such Permits. (b) Credit Parties will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Credit Parties ; business and assets, all Permits necessary under Healthcare Laws to carry on the business of Credit Parties as it is conducted on the Closing Date, except where failure to do so would not reasonably be expected to have a Material Adverse Effect. (cb) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Credit PartyParty or any Subsidiary thereof, each Credit Party shall have, and shall have caused each of its Subsidiaries to have, obtained and comply in all material respects with all material Regulatory Required Permits at all times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Credit Party or its Subsidiaries as such activities are at any such time being conducted by such Credit PartyParty or its Subsidiaries. (dc) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, Credit Parties will, and will cause their Subsidiaries to, timely file or caused to be timely filed (after giving effect to any extension duly obtained), all material notifications, reports, submissions, material Permit renewals and reports required by applicable Healthcare Laws (which reports will be materially accurate and complete in all material respects and not misleading in any material respect and shall not remain open or unsettled).

Appears in 1 contract

Samples: Credit Agreement (Orthopediatrics Corp)

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