Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five (5) Business Days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (v) any Product recalls or voluntary Product withdrawals from any market which have or could reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event.
Regulatory Reporting and Covenants. Except where failure to do so would not reasonably be expected to have a Material Adverse Effect:
Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly, and in any event within three (3) Business Days of receiving, becoming aware of or determining that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”):
Regulatory Reporting and 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 except where failure to do so would not reasonably be expected to have a Material Adverse Effect. Borrower shall ensure that all Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Permits, except where failure to be in such compliance or for a Permit to be valid and in full force and effect would not reasonably be expected to have a Material Adverse Effect.
Regulatory Reporting and Covenants. (a) Each Credit Party shall notify Agent promptly, and in any event within five (5) Business Days of receiving, upon receiving written notice or otherwise becoming aware that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”):
Regulatory Reporting and Covenants. 75 MidCap / ATEC / Credit, Security and Guaranty Agreement
Regulatory Reporting and Covenants. Except where failure to do so would not reasonably be expected to have a Material Adverse Effect: (a) Loan Parties shall have, and shall ensure that it and each of their Subsidiaries has, each Permit from, and have made all material declarations and filings with, all applicable Governmental Authorities necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Loan Party. Loan Parties shall ensure that all Permits are valid and in full force and effect and Loan Parties are in material compliance with the terms and conditions of all such Permits. (b) Loan Parties will maintain in full force and effect, and free from material restrictions, probations, conditions or known conflicts which would impair the use or operation of Loan Parties’ business and assets, all Permits necessary under Healthcare Laws to carry on the business of Loan Parties as it is conducted on the Closing Date. SECTION 7.16
