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.

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 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).

Examples of Market Withdrawal in a sentence

• Day-Ahead Market Withdrawal Settlement Location loss rebate factors are calculated hourly as the difference between the Day-Ahead MLC at a withdrawal Settlement Location in the Loss Pool and the injection weighted average Day-Ahead MLC for the Loss Pool, multiplied by the withdrawal quantity at that withdrawal Settlement Location.

• The Day-Ahead Market Loss Pool loss rebate factor is equal to the sum of the positive loss rebate factors calculated in the Day-Ahead Market at each withdrawal Settlement Location in the Loss Pool (the “Day-Ahead Market Withdrawal Settlement Location loss rebate factor”).

• When an investigation determines there is no evidence of manufacturing or distribution problems, but a firm has removed products from the market as a result of actual or alleged tampering with individual units, the action will be considered a Market Withdrawal.

• Letter from Deborah Shapse, Medical Director, Organon, Inc., Re: Voluntary Market Withdrawal of RAPLON (rapacuronium bromide) for Injection, All Batches (March 27, 2001), http:// www.fda.gov/downloads/Safety/ MedWatch/SafetyInformation/Safety AlertsforHumanMedicalProducts/ UCM173891.pdf.

• Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma.

More Definitions of Market Withdrawal

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 cor- rection or removal of a distributed de- vice that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

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 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 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, CMS, Dutch Minister of Health, IGJ, EMA or any other Governmental Authority 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).

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 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. MidCap / Cerus / Credit, Security and Guaranty Agreement (Term Loan) [***] = Certain Confidential Information Omitted \DC - 036639/000093 - 13934788 v5 202344533 v5