Common use of Regulatory Covenants Clause in Contracts

Regulatory Covenants. (a) Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other rights from, and have made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Borrower shall ensure that all such Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits in all material respects. (b) 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 Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. MidCap / Sientra / Second A&R Credit and Security Agreement (Term) (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Borrower, each Borrower shall obtain and comply in all material respects with all material Regulatory Required Permits at all times issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacture, marketing or sales of such Product by such Borrower as such activities are at any such time being conducted by such Borrower. (d) 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 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.

Regulatory Covenants. (a) 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 Borrower and Borrowers shall take such reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Borrower shall ensure that all such Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits in all material respects.Permits. MidCap / HTG / Credit and Security Agreement (Revolving Loan) \\DC - 036639/000001 - 12092487 (b) 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 Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. MidCap / Sientra / Second A&R Credit and Security Agreement (Term)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 Borrower, each Borrower shall obtain 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 Borrower as such activities are at any such time being conducted by such Borrower. (d) Except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect, 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 sell or market any new Product or obtain a material Regulatory Required Permitcommercially (excluding for the avoidance of doubt any revisions to the Borrower’s existing assays), Borrowers shall deliver written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required Permit) anddeliver, together with delivery of the next Compliance Certificate shall provide Certificate, an updated Schedule 4.17 (and copies of such Permits as Agent may request) to the Disclosure Letter reflecting updates related to such determinationdetermination (which shall also include a brief description of such Product).

Regulatory Covenants. (a) 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 declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall ensure that no Governmental Authority has taken action to limit, suspend or revoke any such material Permit. Borrower shall ensure that all such Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits in all material respects. (b) Borrowers will, and will cause each of its Subsidiaries 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 Borrowers’ or such Subsidiary’s business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Borrowers and its Subsidiaries as it is conducted on the Closing Date in all material respects. MidCap / Sientra / Second A&R Credit and Security Agreement (Term). (c) In connection with the development, testing, manufacture, marketing import, export, holding, marketing, promotion, sale, labeling, or sale distribution of each and any material Product by or on behalf of any BorrowerBorrower or any Subsidiary thereof, each Borrower and Subsidiary shall obtain 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 activities being conducted by or sales behalf of Borrower or such Product by such Borrower as such activities are Subsidiaries at any such time being conducted by such Borrowertime. (d) Borrowers will, and will cause each of its Subsidiaries to, timely file or caused cause to be timely filed (after giving effect to any extension duly obtained), with applicable Governmental Authorities 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 respect and shall not remain open or unsettled). (e) If, after the Closing Date, Borrowers or any of their Subsidiaries determine to manufacture, sell, developdevelop (beyond initial testing), test or market any new Product or obtain a material Regulatory Required PermitProduct, Borrowers shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required PermitProduct) and, together with delivery of the next Compliance Certificate required to be delivered pursuant to Section 4.1 with respect to the last month of a fiscal quarter, shall provide an updated Schedule 4.17 4.15 (and copies of such Permits as Agent may request) reflecting updates related to such determination. (f) Borrower shall notify Agent at least ten (10) Business Days prior to it or any of its Subsidiaries beginning to receive payments from Medicare, Medicaid, or TRICARE. (g) Borrower shall ensure that each Product (i) is not adulterated or misbranded within the meaning of the FDCA or any other applicable Laws in any material respect; (ii) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 505 of the FDCA; (iii) has been and/or shall be developed, tested, manufactured, imported, exported, held, marketed, advertised, promoted, sold, labeled, and distributed, as applicable, and each service has been conducted, in material compliance with all applicable Permits and Laws; and (iv) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices in all material respects.

Regulatory Covenants. (a) Borrowers shall have, and shall ensure that it and each of its Subsidiaries has, each material Permit and other rights from, and have made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to to, in all material respects, engage in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Permit. Borrower shall ensure that all such Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits in all material respects. (b) 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 Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. MidCap / Sientra / Second A&R Credit and Security Agreement (Term). (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Borrower, each Borrower shall obtain 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 material Product by such Borrower as such activities are at any such time being conducted by such Borrower. (d) 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 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 PermitProduct, Borrowers shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product or Regulatory Required PermitProduct) 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.

Regulatory Covenants. (a) Borrowers 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 Borrower and 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. Borrower Borrowers shall ensure that all such Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits in all material respectsexcept where the failure to do so would not reasonably be expected to have a Material Adverse Effect. (b) 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 Borrowers’ business and assets, all material Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. MidCap / Sientra / Second A&R Credit and Security Agreement (Term) (c) In connection with the development, testing, manufacture, marketing or sale of each and any material Product by any Borrower, each Borrower shall obtain 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 Borrower as such activities are at any such time being conducted by such Borrower, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect. (dc) 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 respect and shall not remain open or unsettled)expected to have a Material Adverse Effect. (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.