Regulatory Matters, Etc. (i) The FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, or the manufacturing facilities therefore, that causes such Person the loss of more than ten percent (10%) of the Borrower’s revenue for the twelve (12) month period following such enforcement action as compared to the same period ending on the same date in the prior period, or (ii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $500,000 to the extent not covered by insurance.
Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor, any Product or any manufacturing facilities for Trudhesa (the “Specified Products”) that causes any Obligor to discontinue or withdraw, or could reasonably be expected to cause any Obligor to discontinue or withdraw, marketing or sales of any Specified Product, or causes a delay in the manufacture or sale of any Specified Product, which discontinuance or delay could reasonably be expected to last for more than forty five (45) days and would reasonably be expected to result in a Material Adverse Effect, or (ii) a recall of any Specified Product that has generated or is expected to generate at least $10,000,000 (or the Equivalent Amount in other currencies) in revenue for the Borrower and its Subsidiaries for sales or licenses to third parties over any period of twelve (12) consecutive months or (iii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority in respect of the Specified Products that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $10,000,000 (or the Equivalent Amount in other currencies).
Regulatory Matters, Etc. If any of the following occurs:(i) the FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor, any Product or any manufacturing facilities that any Obligor owns or controls related to the foregoing that (x) causes any Obligor to discontinue or withdraw, or would reasonably be expected to cause any Obligor to discontinue or withdraw, marketing or sales of a Product or causes a delay in the manufacture or sale of a Product and (y) would reasonably be expected to result in a Material Adverse Effect, or (ii) a recall of a Product that would reasonably be expected to result in a Material Adverse Effect.
Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority (whether U.S. or non-U.S.) initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Obligor to discontinue or withdraw, or could reasonably be expected to cause any Obligor to discontinue or withdraw, Product Development and Commercialization Activities with respect to any Product, or otherwise causes a delay in the manufacture or sale of any Product, which discontinuance or delay could reasonably be expected to last for more than 30 days, (ii) a recall of any Product that has generated or is expected to generate at least $2,000,000 in revenue for the Borrower and its Subsidiaries over any period of twelve consecutive months or (iii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $750,000.
Regulatory Matters, Etc. There occurs any of the following: (i) the FDA or any other Regulatory Authority initiates an enforcement action against, or issues a warning letter with respect to, any Loan Party or any of their respective Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Loan Party or any of their respective Subsidiaries to discontinue or withdraw, or would reasonably be expected to cause any Loan Party to discontinue or withdraw, marketing or sales of any Product that has generated or is expected to generate at least $250,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months, or causes a delay in the manufacture or sale of any such Product, which discontinuance or delay would reasonably be expected to last for more than thirty (30) days, (ii) a recall of any Product that has generated or is expected to generate at least $250,000 in revenue for the Loan Parties and their respective Subsidiaries on a consolidated basis over any period of twelve (12) consecutive months or (iii) any Loan Party enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $250,000; or
Regulatory Matters, Etc. A Material Regulatory Event shall have occurred.
Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, the Borrower or any of its Subsidiaries, any Product or any manufacturing facilities for any Product that causes the Borrower or any such Subsidiary to discontinue or withdraw, or could reasonably be expected to cause such Person to discontinue or withdraw, marketing or sales of any Product, or causes a delay in the manufacture or sale of any Product, which discontinuance or delay (x) could reasonably be expected to last for more than ninety (90) days and (y) the Loss of Revenue during the period of such discontinuance, withdrawal or delay (assuming a minimum period of 90 days) could reasonably be expected to be in an amount in excess of ten percent (10%) of total Revenue for the Borrower and its Subsidiaries for the most recently ended period of twelve (12) consecutive months, (ii) a recall of any Product that has generated or is expected to generate at least $1,500,000 in revenue for the Borrower and its Subsidiaries over any period of twelve (12) consecutive months or (iii) the Borrower or any of its Subsidiaries enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $1,500,000 to the extent not covered by independent third-party insurance as to which the insurer does not dispute coverage.
Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other U.S. Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to BXCL 501 that causes any Obligor to discontinue or withdraw, or would reasonably be expected to cause any Obligor to discontinue or withdraw, marketing or sales BXCL 501, or causes a material delay in the manufacture or sale of BXCL 501, which discontinuance or delay would reasonably be expected to last for more than ninety (90) days, (ii) an FDA Class 1 Recall of BXCL 501 in the U.S., to the extent BXCL 501 has generated or is expected to generate at least $[***] (or the Equivalent Amount in other currencies) in revenue for the Borrower and its Subsidiaries for sales or licenses to third parties over any period of twelve (12) consecutive months, or (iii) any Obligor enters into a settlement agreement with the FDA or any other U.S. Regulatory Authority in respect of BXCL 501 that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $[***] (or the Equivalent Amount in other currencies).
Regulatory Matters, Etc. (a) From and after the Closing Date, Buyer shall assume all regulatory responsibilities in connection with the Products and the Product Applications, including responsibility for (i) all periodic and annual reports or other regulatory filings with the FDA or any equivalent foreign Governmental Authority with respect to the 2007 calendar year (provided that Selling Parties shall provide assistance as reasonably requested in connection with such reports and filings), (ii) reporting any product quality complaints and adverse drug events in connection with the NDA, and (iii) compliance with the Federal Food, Drug and Cosmetic Act and the Public Health Service Act, as the same may be amended from time to time. For a period of six (6) months after the Closing Date, if the Selling Parties receive any adverse event reports regarding the Product, the Selling Parties shall promptly notify Buyer of such.
(b) Notwithstanding anything in this Agreement to the contrary and subject to Section 2.7, the Selling Parties shall have no obligation whatsoever in connection with any regulatory filings, requests or applications related to the Product.
(c) From and after the Closing Date, the Selling Parties shall direct all complaints or inquiries concerning the Product to Buyer to the attention of the “Senior Director of Medical Affairs” of Buyer, or such other person or persons as Buyer may specify from time to time by written notice to the Selling Parties.
(d) From and after the Closing Date, Buyer shall have all responsibility for any and all Governmental Authority fee obligations for holders or owners of the Product Registration and the Product Applications that relate to periods on or after the Closing Date, and the Selling Parties shall retain responsibility for such fee obligations as they relate to periods prior to the Closing Date. Each party shall promptly reimburse the other to the extent a party pays amounts that are the responsibility of the other party hereunder.
(e) From and after the Closing Date, Buyer shall have the sole authority and responsibility to respond to any Governmental Authorities, to respond to product technical complaints and medical complaints and to handle all recalls, market withdrawals and field corrections of the Product in accordance with applicable Laws, all at Buyer’s sole cost and expense.
(f) Beginning at the Closing Date and ending two (2) years thereafter, Buyer shall promptly (but in any case, within forty-eight (48) hours) notify the ...
Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor or FUROSCIX or, to the knowledge of the Obligors, any manufacturing facilities related to the foregoing that (x) causes any Obligor to discontinue or withdraw, marketing or sales of FUROSCIX, or causes a delay in the manufacture or sale of FUROSCIX, and (y) results in a Material Adverse Effect, or (ii) a recall of FUROSCIX that results in a Material Adverse Effect.
