Market Withdrawal definition

Market Withdrawal means a Person’s Removal or Correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

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Market Withdrawal means the voluntary removal of medical cannabidiol from dispensaries and patients by a manufacturer for minor issues that do not pose a serious health threat.

Market Withdrawal means a Person’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc., as that term is defined in 21 C.F.R. 7.3(j).

Examples of Market Withdrawal in a sentence

• None of the Products (for the avoidance of doubt, including those in the immediately preceding two sentences that have been so finally and fully completed) have been subject to a Recall, Market Withdrawal, or other Correction or Removal, nor is any such action currently under consideration by Endologix or, to the knowledge of Endologix, any manufacturer or supplier of a Product, that could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.

• Each Party shall provide the Independent Expert with the documentation in support of its Estimated Market Withdrawal Adjustment, and the Independent Expert shall keep such documentation confidential and shall not share it with the other Party.

• Within [*] days of its appointment, the Independent Expert shall, after having made its own estimate of the Market Withdrawal Adjustment, determine the Market Withdrawal Adjustment by selecting (a) the High Value or (b) the Low Value, whichever is closer to its own estimate of the Market Withdrawal Adjustment.

• If one Party fails to deliver an Estimated Market Withdrawal Notice within [*] days of the date of the Market Withdrawal Adjustment Resolution Date, then the other Party’s determination of the Market Withdrawal Adjustment shall be considered final and binding on the Parties.

• BMS shall, within [*] days after receipt of such notice indicate to Sanofi whether it objects to Sanofi’s determination that a Market Withdrawal has occurred.

More Definitions of Market Withdrawal

Market Withdrawal has the same meaning and usage as 21 C.F.R. 806.1(i) stating that a Person’s removal from any market or correction of a Product that involves a minor violation that would not be subject to legal action by the FDA or that involves no violation.

Market Withdrawal means the removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, such as normal stock rotation practices and routine equipment adjustments and repairs, as this term is defined in FDA’s regulations at 21 CFR 7.3(j).

Market Withdrawal means a Person’s Removal or Correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA (or any applicable and comparable state or local Governmental Authority, any applicable and comparable Governmental Authority in any applicable non-United States jurisdiction), or which involves no violation, such as routine stock rotation practices or routine equipment adjustments and repairs.

Market Withdrawal means a withdrawal of a Product from the market in a country or countries which has or is reasonably expected to have an adverse effect (which is material) on sales of such Product respectively, in Territory A, or all the Territory A Opt-out Country(ies), as a whole, and is (a) mandated by a Governmental Authority; (b) implemented by Sanofi or its Affiliates in anticipation of a withdrawal that Sanofi believes in good faith to be reasonably likely to be mandated in the future by a Governmental Authority (either by reason of statements from such Governmental Authority, mandated withdrawals in other jurisdictions or other objective facts); or (c) implemented by Sanofi or its Affiliates in lieu of complying with new requirements or conditions imposed by a Governmental Authority, which requirements or conditions are reasonably expected by Sanofi to have an adverse effect (which is material) on sales of such Product in such country or result in material costs and other burdens to Sanofi or its Affiliates in respect of such Product in such country, which expectation is reasonably supported by available facts; in each case, to the extent such Governmental Authority mandated withdrawal or the imposition of such requirements or conditions by a Governmental Authority is not attributable to acts or omissions of Sanofi or its Affiliates that constitute negligence or willful misconduct. For purposes of this Agreement, Sanofi’s or its Affiliate’s withdrawal or decision to withdraw a Product by Sanofi (instead of complying with a new requirement or condition of a Governmental Authority contemplated under clause (c) above) shall not in and of itself be deemed to be negligent or willful misconduct.

Market Withdrawal means a Person’s Removal or Correction of a distributed Inventory which involves a minor violation that would not be subject to legal action by any Governmental Authority or which involves no violation, including but not limited to normal stock rotation practices, routine equipment adjustments and repairs.

Market Withdrawal means the partial or total withdrawal of any Product in the Territory either on a temporary or permanent basis.

Market Withdrawal means a firm's Removal or Correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.