Withdrawals, Recalls, Adverse Test Results and Other Matters Sample Clauses

Withdrawals, Recalls, Adverse Test Results and Other Matters. (a) The institution of any proceeding by FDA or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin Borrower or any representative of Borrower from manufacturing, marketing, selling or distributing any Product or Product category, (b) the institution of any action or proceeding by any DEA, FDA, or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Required Permit held by Borrower or any representative of Borrower, which, in each case, could cause a Material Adverse Change, (c) the commencement of any enforcement action against Borrower by DEA, FDA, or any other Governmental Authority, (d) the recall of any Products from the market, the voluntary withdrawal of any Products from the market, or actions to discontinue the sale of any Products, or (e) the occurrence of adverse test results in connection with a Product which could cause a Material Adverse Change.
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Withdrawals, Recalls, Adverse Test Results and Other Matters. (a) The institution of any proceeding by FDA, Health Canada, or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin Borrower or its Subsidiary from manufacturing, marketing, selling or distributing any Product or Product category that could reasonably be expected to have a Material Adverse Effect, (b) the institution of any action or proceeding by any DEA, FDA, Health Canada or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Required Permit held by Borrower or its Subsidiary or any of their representatives, which, in each case, could reasonably be expected to have a Material Adverse Effect, (c) the commencement of any enforcement action against Borrower or its Subsidiary by DEA, FDA, Health Canada or any other Governmental Authority that could reasonably be expected to have a Material Adverse Effect, (d) the recall of any Products from the market, the voluntary withdrawal of any Products from the market, or actions to discontinue the sale of any Products that could reasonably be expected to have a Material Adverse Effect, (e) the occurrence of adverse test results in connection with a Product which could reasonably be expected to have a Material Adverse Effect or (i) any termination of (or material default by any Person party thereto that would give any such party the right to terminate) (i) that certain Sales, Marketing & Distribution Agreement, dated as of June 30, 2008, by and between Actavis Group PTC ehf, an Iceland corporation, and Borrower as may be modified, amended, replaced or restated from time to time or (ii) that certain License Agreement, dated as of November 9, 2010, by and between Nautilus Neurosciences, Inc., a Delaware corporation, and Borrower as may be modified, amended, replaced or restated from time to time; if, in the case of either clauses (e)(i) and/or (ii), the exclusion of all revenue received by or on behalf of Borrower and its Subsidiaries in relation to such agreement(s) during each of the four (4) preceding Fiscal Quarters would have resulted in Borrower no longer having been in compliance with Section 7.13.2 hereof during any such Fiscal Quarter, or such future exclusion could reasonably be expected to result in Borrower not being in compliance with such Section on a go-forward basis. CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION H...
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Withdrawals, Recalls, Adverse Test Results and Other Matters. (a) The institution of any proceeding by FDA or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin Borrower or any representative of Borrower from manufacturing, marketing, selling or distributing any Product or Product category, which, in each case, could cause a Material Adverse Change (b) the institution of any action or proceeding by any DEA, FDA, or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Required Permit held by Borrower or any representative of Borrower, which, in each case, could cause a Material Adverse Change, (c) the commencement of any enforcement action against Borrower by DEA, FDA, or any other Governmental Authority, (d) the recall of any Products from the market, the voluntary withdrawal of any Products from the market, or actions to discontinue the sale of any Products, which, in each case, could cause a Material Adverse Change, or (e) the occurrence of adverse test results in connection with a Product which could cause a Material Adverse Change.
Sample 1
Withdrawals, Recalls, Adverse Test Results and Other Matters. Borrower ceases clinical development of PMX-30063 as a result of either (i) an internal decision to cease all further clinical testing in humans for all indications or (ii) the institution of any action or proceeding by any Regulatory Authority to cause Borrower to cease all further clinical testing in humans for all indications. In and of itself, (i) the failure of any nonclinical or clinical trial to demonstrate the desired safety or efficacy or (b) the denial, delay or limitation of approval of, or taking of any other regulatory action by, any Regulatory Authority shall not constitute an Event of Default under this Section 8.14.
Sample 1
Withdrawals, Recalls, Adverse Test Results and Other Matters. (a) The institution of any proceeding by FDA or similar Governmental Authority to order the withdrawal of any Product from the market or to enjoin Borrower or any representative of Borrower from manufacturing, marketing, selling or distributing any Product where such event could reasonably be expected to have a Material Adverse Change, (b) the institution of any action or proceeding by any DEA, FDA, or any other Governmental Authority to revoke, suspend, reject or withdraw any Required Permit held by Borrower or any representative of Borrower, which, in each case, could reasonably be expected to cause a Material Adverse Change, (c) the commencement of any enforcement action against Borrower by DEA, FDA, or any other Governmental Authority, (d) the recall of any Products from the market, the voluntary withdrawal of any Products from the market, or actions to discontinue the sale of any Products, which, in each case, could reasonably be expected to have a Material Adverse Change or (e) the occurrence of adverse test results in connection with a Product which could reasonably be expected to cause a Material Adverse Change.
Sample 1
Withdrawals, Recalls, Adverse Test Results and Other Matters. The institution of any proceeding by FDA or similar Governmental Authority to order the withdrawal of any Sale Compound from the market due to defects in the market or to enjoin Borrower or any representative of Borrower from manufacturing, marketing, selling or distributing any Sale Compound, which, in each case, could reasonably be expected to result
Sample 1
Withdrawals, Recalls, Adverse Test Results and Other Matters. (a) The institution of any proceeding by FDA or similar Governmental Authority to order the withdrawal of any Product or Product category from the market or to enjoin Borrower or any representative of Borrower from manufacturing, marketing, selling or distributing any Product or Product category (other than, after the consummation of the Meda Royalty Monetization Transaction, with respect to a Product whose sales are the subject of a Meda Royalty Monetization Transaction), which, in Agent’s reasonable judgment, is likely to cause a Material Adverse Change, (b) the institution of any action or proceeding by any DEA, FDA, or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Required Permit held by Borrower or any representative of Borrower, which, in each case, in Agent’s reasonable judgment, is likely to cause a Material Adverse Change, (c) the commencement of any enforcement action against Borrower by DEA, FDA, or any other Governmental Authority, (d) the recall of any Products from the market, the voluntary withdrawal of any Products from the market, or actions to discontinue the sale of any Products, which in Agent’s reasonable judgment, is likely to cause a Material Adverse Change, or (e) the occurrence of adverse test results in connection with a Product which in Agent’s reasonable judgment, is likely to cause a Material Adverse Change.
Sample 1
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Related to Withdrawals, Recalls, Adverse Test Results and Other Matters

  • Financial Reports and Other Information (a) The Borrower will maintain a system of accounting in accordance with GAAP and will furnish to the Lenders and their respective duly authorized representatives such information respecting the business and financial condition of the Borrower and its Subsidiaries as any Lender may reasonably request. The Borrower shall deliver (via email or otherwise) to the Administrative Agent in form and detail satisfactory to the Administrative Agent, with copies for each Lender in form and substance satisfactory to them, each of the following:

  • Financial Statements; Borrowing Base and Other Information The Borrowers will furnish to the Administrative Agent and each Lender:

  • Financial Statements and Other Information The Borrower will furnish to the Administrative Agent and each Lender:

  • Financial Statements; Ratings Change and Other Information The Borrower will furnish to the Administrative Agent and each Lender:

  • Financial Statements; No Material Adverse Effect (a) The Audited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; (ii) fairly present the financial condition of the Borrower and its Subsidiaries as of the date thereof and their results of operations for the period covered thereby in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; and (iii) show all material indebtedness and other liabilities, direct or contingent, of the Borrower and its Subsidiaries as of the date thereof, including liabilities for taxes, material commitments and Indebtedness.

  • Financial Statements; Material Adverse Change The consolidated balance sheet of such Borrower and its Subsidiaries, as at December 31, 2020, and the related consolidated statements of income, retained earnings and cash flows of such Borrower and its Subsidiaries, certified by PricewaterhouseCoopers LLP, independent public accountants, and the unaudited consolidated balance sheet of such Borrower and its Subsidiaries, as at June 30, 2021, and the related consolidated statements of income, retained earnings and cash flows of such Borrower and its Subsidiaries, for the six months then ended, copies of which have been furnished to each Lender and each Fronting Bank, in all cases as amended and restated to the date hereof, present fairly in all material respects the consolidated financial position of such Borrower and its Subsidiaries as at the indicated dates and the consolidated results of the operations of such Borrower and its Subsidiaries for the periods ended on the indicated dates, all in accordance with GAAP consistently applied (in the case of such statements that are unaudited, subject to year-end adjustments and the exclusion of detailed footnotes). Except as disclosed in the Disclosure Documents, there has been no change, event or occurrence since December 31, 2020 that has had a Material Adverse Effect with respect to such Borrower.

  • Reports and Other Information (a) The Fund and the Investment Manager agree to furnish to each other, if applicable, current prospectuses, proxy statements, reports to shareholders, certified copies of their financial statements, and such other information with respect to their affairs as each may reasonably request. The Investment Manager further agrees to furnish to the Fund, if applicable, the same such documents and information pertaining to any sub-adviser as the Fund may reasonably request.

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