Common use of Withdrawals, Recalls, Adverse Test Results and Other Matters Clause in Contracts

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 HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

Withdrawals, Recalls, Adverse Test Results and Other Matters. In addition to the Events of Default described in Section 8.10, (a) The the institution of any proceeding by FDA, Health Canada, the FDA or similar Governmental Authority to order the withdrawal of any Product product or Product product category from the market or to enjoin Borrower or its Subsidiary any representative of Borrower from manufacturing, marketing, selling or distributing any Product product or Product category that could product category, which institution of proceeding has, or would reasonably be expected to have have, a Material Adverse Effectmaterial adverse effect of Borrower’s business, (b) the institution of any action or proceeding by any DEA, FDA, Health Canada the FDA or any other Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict any Required Permit Governmental Approval held by Borrower or its Subsidiary or any representative of their representativesBorrower, whichwhich action, in each case, could has, or would reasonably be expected to have have, a Material Adverse Effectmaterial adverse effect of Borrower’s business, (c) the commencement of any enforcement action against Borrower or its Subsidiary by DEA, FDA, Health Canada the FDA or any other Governmental Authority that could Authority, which commencement of action has, or would reasonably be expected to have have, a Material Adverse Effectmaterial adverse effect of Borrower’s business, (d) the recall of any Products products from the market, the voluntary withdrawal of any Products products from the market, or actions to discontinue the sale of any Products that could products, which recall, withdrawal or action has, or would reasonably be expected to have have, a Material Adverse Effectmaterial adverse effect of Borrower’s business, or (e) the occurrence of adverse test results in connection with a Product product which could would reasonably be expected to have a Material Adverse Effect or (i) any termination material adverse effect 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 HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSIONBorrower’s business.