Notification and Determination Sample Clauses

Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field whether inside the Territory or outside the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) business day, after receipt thereof. Notwithstanding the foregoing, in all cases Pfizer (acting as the holder of the Product Approval in the Territory) shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory, and Auxilium, as holder of the Product Approval outside the Territory shall determine whether to initiate any such recall, withdrawal or market notification of the Product outside the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or market notification; provided, however that before Pfizer or Auxilium (as the case may be) initiates a recall, withdrawal or market notification, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that Pfizer or Auxilium (as the case may be) reasonably believes has to be taken in relation to any recall, withdrawal or market notification. In the event of any such recall, withdrawal or market notification, Pfizer or Auxilium (as the case may be), as the distributor of the Product, shall determine the necessary actions to be taken, and, shall implement such action, with the other Party providing reasonable input (which the first Party shall in good faith consider and incorporate into any recall, withdrawal or market notification strategy) and reasonable assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, Auxilium shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by Pfizer, but Pfizer, acting as the holder of the Product Approval in the Territory, shall make the final decision as to whether or not the recall, withdrawal or market notification will be initiated. Pfizer shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 5.7.1...
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Notification and Determination. In the event that any Governmental Authority threatens, initiates or recommends any voluntary or involuntary action to remove Product from the market in the Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) Business Day, after receipt thereof. In all cases, Prestwick shall make the final determination regarding whether or not to initiate any recall or withdrawal of Product in the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall); provided, however, that before Prestwick determines whether or not to initiate a recall or withdrawal, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided further that such discussions shall not delay any action that Prestwick reasonably believes has to be taken in relation to any recall. In the event of any such recall or withdrawal, whether voluntary or involuntary, Distributor shall implement any necessary action, with assistance from Prestwick as reasonably requested by Distributor, to conduct such recall or withdrawal. Distributor shall utilize a batch tracing and recall system which will enable Distributor to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers in accordance with Prestwick’s instructions.
Sample 1See All (4)
Notification and Determination. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than one (1) Business Day, after receipt thereof. In all cases, EUSA shall determine whether to initiate any recall or withdrawal of the Product in the Territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall); provided, however, that before EUSA initiates a recall or withdrawal, the Parties shall promptly meet and discuss in good faith the reasons therefor, provided further that such discussions shall not delay any action that EUSA reasonably believes has to be taken in relation to any recall or withdrawal. In the event of any such recall or withdrawal, EUSA shall implement any necessary action, with assistance from Innocoll as requested by EUSA, to conduct such recall or withdrawal.
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Notification and Determination. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to a recall (whether voluntary or mandated), corrective action, or similar regulatory action by any Governmental Authority or Regulatory Authority (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the applicable Territory, and otherwise reasonably cooperate with each other with respect to such Remedial Action or potential Remedial Action. Xxxxx will have sole discretion and final decision-making authority with respect to, and control over, any Remedial Action in the Ionis Territory, including any decision to commence such Remedial Action in the Ionis Territory. Otsuka will have sole discretion and final decision-making authority with respect to, and control over, any Remedial Action in the Otsuka Territory, including any decision to commence such Remedial Action in the Otsuka Territory; provided that if Ionis notifies Otsuka of [***] that Ionis reasonably believes could give rise to a Remedial Action, then Otsuka will initiate such Remedial Action in accordance with Ionis’ request and at [***].
Sample 1
Notification and Determination. In the event that any Regulatory Authority threatens or initiates any action to remove a Licensed Product from the market, the Party receiving notice thereof shall notify the other Party of such communication immediately (but in no event later than [***]hours after receipt thereof).
Sample 1
Notification and Determination. If any Governmental Authority threatens in writing or initiates any action to remove a Licensed Product from the market (in whole or in part) in the Territory, then the Party receiving notice thereof will notify the other Party of such communication immediately, but in no event later than [***] after receipt thereof. Notwithstanding the foregoing, in all cases GSK will determine whether to initiate any recall, withdrawal or field alert of such Licensed Product in the applicable territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert. Before GSK initiates a recall, withdrawal, or field alert for a Licensed Product in the Territory the Parties will promptly meet and discuss in good faith the reasons therefor, provided that such discussions will not delay any action that GSK reasonably believes should be taken in relation to any actual or potential recall, withdrawal or field alert. In the event of any such recall, withdrawal, or field alert, GSK will determine the necessary actions to be taken and will implement such action. Without limiting the foregoing, either Party will have the right to propose that a recall, withdrawal or field alert for a Licensed Product should be initiated by such Party, but GSK will have the right to make the final decision as to whether or not to initiate the recall, withdrawal or field alert. Notwithstanding the foregoing, if ITEOS notifies GSK of a Manufacturing issue related to a Licensed Product that ITEOS had Manufactured during the October 2021 Campaign and that ITEOS reasonably believes could give rise to a recall, withdrawal or field alert, then GSK will initiate such recall, withdrawal, or field alert in accordance with ITEOS’s request.
Sample 1
Notification and Determination. If any Governmental Authority (a) threatens in writing, or initiates, any action to remove any Product or Non-Systemic Ophthalmology Product from the market (in whole or in part) or (b) provides written notice regarding a potential safety or quality issue with respect to any Product or Non-Systemic Ophthalmology Product, then, in each case ((a) or (b)), the Party receiving notice thereof will notify the other Party of such communication promptly, but in no event later than [**] after receipt thereof. Notwithstanding the foregoing, in all cases Sobi shall determine whether to initiate any recall, withdrawal, or field alert of any Product in any country in the Sobi Territory and Apellis shall determine whether to initiate any recall, withdrawal, or field alert of any Product in the Apellis Territory or any Non-Systemic Ophthalmology Product anywhere in the world, including, in each case, the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert. Before either Party initiates a recall, withdrawal, or field alert relating to a Product, the Party initiating such recall, withdrawal, or field alert shall notify the other Party within [**] of such decision and the Parties shall use reasonable efforts to promptly discuss in good faith the reasons therefor, but such discussions will not delay any action that the Party initiating such recall reasonably believes should be taken in relation to any actual or potential recall, withdrawal, or field alert. In the event of any such recall, withdrawal, or field alert relating to a Product, the Party initiating such recall, withdrawal, or field alert shall determine the necessary actions to be taken and will implement such actions.
Sample 1
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Notification and Determination. In the event that any Governmental Authority threatens in writing or initiates any action to remove a SYNGAP1 Co-Co Product from the market (in whole or in part) in the Territory, the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than [***] after receipt thereof. Notwithstanding the foregoing, in all cases the Lead Regulatory Party for a SYNGAP1 Co-Co Product in a country shall determine whether to initiate any recall, withdrawal, or field alert of such SYNGAP1 Co-Co Product in such country, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert. Before the Lead Regulatory Party initiates a recall, withdrawal, or field alert for a SYNGAP1 Co-Co Product in a country, the Parties shall use reasonable efforts to promptly meet and discuss in good faith the reasons therefor, provided that such discussions shall not delay any action that such Lead Regulatory Party reasonably believes should be taken in relation to any actual or potential recall, withdrawal, or field alert. In the event of any such recall, withdrawal, or field alert, the Lead Regulatory Party for the applicable country shall determine the necessary actions to be taken and shall implement such action. Without limiting the foregoing, either Party shall have the right to propose that a recall, withdrawal, or field alert for a SYNGAP1 Co-Co Product should be initiated by such Party, but the Lead Regulatory Party for the applicable country shall have the right to make the final decision as to whether or not to initiate the recall, withdrawal, or field alert.
Sample 1
Notification and Determination. If a Party receives any notice from a Governmental Authority threatening or initiating any action to remove the Lead DMD Product from the market, the Party receiving notice thereof shall notify the other Party of such communication as promptly as practicable but in no event later than within the time frames agreed in the applicable Quality Agreement.
Sample 1

Related to Notification and Determination

  • Calculations and Determinations The Calculation Agent shall in respect of each Series of Notes in relation to which it is appointed as such:

  • Notification and Determination of Additional Costs Each of the Administrative Agent and each Lender and each Participant (through its participating Lender), as the case may be, agrees to notify the Borrower of any event occurring after the Agreement Date entitling the Administrative Agent or such Lender or such Participant to compensation under any of the preceding subsections of this Section as promptly as practicable; provided, however, the failure of the Administrative Agent or any Lender or any Participant (through its participating Lender) to give such notice shall not release the Borrower from any of their obligations hereunder. Notwithstanding the foregoing, the Borrower shall not be required to compensate the Administrative Agent, any Lender or any Participant pursuant to the foregoing provisions of this Section for any increased costs incurred or reductions suffered more than six months prior to the date that the Administrative Agent or such Lender or such Participant (through its participating Lender) notifies the Borrower of the Regulatory Change giving rise to such increases costs or reductions and of the Administrative Agent’s or such Lender’s or such Participant’s intention to claim compensation therefor (except that, if the Regulatory Change giving rise to such increased costs or reductions is retroactive, then the six-month period referred to above shall be extended to include the period of retroactive effect thereof). The Administrative Agent or such Lender or such Participant (through its participating Lender) agrees to furnish to the Borrower (and in the case of a Lender or a Participant, to the Administrative Agent) a certificate setting forth in reasonable detail the basis and amount of each request by the Administrative Agent or such Lender for compensation under this Section. Absent manifest error, determinations by the Administrative Agent or any Lender or any Participant of the effect of any Regulatory Change shall be conclusive, provided that such determinations are made on a reasonable basis and in good faith.

  • Opinions and Determinations Where the terms of this Contract provide for action to be based upon opinion, judgment, approval, review, or determination of either party hereto, such terms are not intended to be and shall never be construed as permitting such opinion, judgment, approval, review, or determination to be arbitrary, capricious, or unreasonable.

  • Certificates and determinations Any certification or determination by a Finance Party of a rate or amount under any Finance Document is, in the absence of manifest error, conclusive evidence of the matters to which it relates.

  • Accounting Terms and Determination Unless otherwise defined or specified herein, all accounting terms used herein shall be interpreted, all accounting determinations hereunder shall be made, and all financial statements required to be delivered hereunder shall be prepared, in accordance with GAAP as in effect from time to time, applied on a basis consistent with the most recent audited consolidated financial statement of the Borrower delivered pursuant to Section 5.1(a); provided, that (a) obligations relating to a lease that were (or would be) classified and accounted for by Borrower and its Restricted Subsidiaries as an operating lease under GAAP as in effect on the Closing Date shall continue to be classified and accounted for as obligations relating to an operating lease and not as a capitalized lease notwithstanding Accounting Standards Codification 840 or Accounting Standards Codification 842 or any implementation thereof, and (b) if the Borrower notifies the Administrative Agent that the Borrower wishes to amend the Total Net Leverage Ratio, the Senior Secured Net Leverage Ratio or the First Lien Net Leverage Ratio to eliminate the effect of any change in GAAP occurring after the Closing Date on the operation of the Total Net Leverage Ratio, the Senior Secured Net Leverage Ratio or the First Lien Net Leverage Ratio, as applicable (or if the Administrative Agent notifies the Borrower that the Required Lenders wish to amend the Total Net Leverage Ratio, the Senior Secured Net Leverage Ratio or the First Lien Net Leverage Ratio for such purpose), then the Borrower’s calculation of the Total Net Leverage Ratio, the Senior Secured Net Leverage Ratio, the First Lien Net Leverage Ratio and/or compliance with the Financial Covenant, as applicable, shall be determined on the basis of GAAP in effect immediately before the relevant change in GAAP became effective, until either such notice is withdrawn or the Total Net Leverage Ratio, the Senior Secured Net Leverage Ratio, the First Lien Net Leverage Ratio and/or the Financial Covenant, as applicable, is amended in a manner satisfactory to the Borrower and the Required Lenders. Notwithstanding any other provision contained herein, (i) all terms of an accounting or financial nature used herein shall be construed, and all computations of amounts and ratios referred to herein shall be made, without giving effect to any election under FASB ASC 825 (or any other Financial Accounting Standard having a similar result or effect) to value any Indebtedness or other liabilities of the Borrower or any Restricted Subsidiary at “fair value”, as defined therein and (ii) there shall be excluded from any financial calculations hereunder or under any other Loan Document the Consolidated EBITDA, Consolidated Net Income, Cash and other assets of any Unrestricted Subsidiary, except to the extent actually distributed to the Borrower or any of its Restricted Subsidiaries by dividend or other distribution prior to such calculation.

  • Accounting Terms and Determinations Except as otherwise expressly provided herein, all accounting terms used herein shall be interpreted, and all financial statements and certificates and reports as to financial matters required to be delivered to the Lender hereunder shall be prepared, in accordance with GAAP.

  • Accounting Terms and Determinations; GAAP Unless otherwise specified herein, all accounting terms used herein shall be interpreted, all determinations with respect to accounting matters hereunder shall be made, and all financial statements and certificates and reports as to financial matters required to be furnished to the Administrative Agent or the Lenders hereunder shall be prepared, in accordance with GAAP, applied on a basis consistent with the Financial Statements except for changes in which Borrower’s independent certified public accountants concur and which are disclosed to Administrative Agent on the next date on which financial statements are required to be delivered to the Lenders pursuant to Section 8.01(a); provided that, unless the Borrower and the Majority Lenders shall otherwise agree in writing, no such change shall modify or affect the manner in which compliance with the covenants contained herein is computed such that all such computations shall be conducted utilizing financial information presented consistently with prior periods.

  • Notices; Standards for Decisions and Determinations The Administrative Agent will promptly notify the Borrower and the Lenders of (A) the implementation of any Benchmark Replacement and (B) the effectiveness of any Conforming Changes. For the avoidance of doubt, any notice required to be delivered by the Administrative Agent as set forth in this Section 12.01(c) may be provided, at the option of the Administrative Agent (in its sole discretion), in one or more notices and may be delivered together with, or as part of any amendment which implements any Benchmark Replacement or Conforming Changes. Any determination, decision or election that may be made by the Administrative Agent or, if applicable, any Lender (or group of Lenders) pursuant to this Section 12.01(c), including any determination with respect to a tenor, rate or adjustment or of the occurrence or non-occurrence of an event, circumstance or date and any decision to take or refrain from taking any action, will be conclusive and binding absent manifest error and may be made in its or their sole discretion and without consent from any other party hereto, except, in each case, as expressly required pursuant to this Section 12.01(c).

  • DRUG ABUSE DETECTION AND DETERRENCE 2.18.1 It is the policy of the City to achieve a drug-free workforce and workplace. The manufacture, distribution, dispensation, possession, sale, or use of illegal drugs or alcohol by contractors while on City Premises is prohibited. Contractor shall comply with all the requirements and procedures set forth in the Mayor’s Drug Abuse Detection and Deterrence Procedures for Contractors, Executive Order No. 1-31 (the “Executive Order”), which is incorporated into this Agreement and is on file in the City Secretary’s Office. 2.18.2 Before the City signs this Agreement, Contractor shall file with the Contract Compliance Officer for Drug Testing (“CCODT”): 2.18.2.1 a copy of its drug-free workplace policy; 2.18.2.2 the Drug Policy Compliance Agreement substantially in the form set forth in Exhibit “C”, together with a written designation of all safety impact positions; and 2.18.2.3 if applicable (e.g., no safety impact positions), the Certification of No Safety Impact Positions, substantially in the form set forth in Exhibit “D”. 2.18.3 If Contractor files a written designation of safety impact positions with its Drug Policy Compliance Agreement, it also shall file every 6 months during the performance of this Agreement or on completion of this Agreement if performance is less than 6 months, a Drug Policy Compliance Declaration in a form substantially similar to Exhibit “E”. Contractor shall submit the Drug Policy Compliance Declaration to the CCODT within 30 days of the expiration of each 6-month period of performance and within 30 days of completion of this Agreement. The first 6- month period begins to run on the date the City issues its Notice to Proceed or, if no Notice to Proceed is issued, on the first day Contractor begins work under this Agreement. 2.18.4 Contractor also shall file updated designations of safety impact positions with the CCODT if additional safety impact positions are added to Contractor’s employee work force. 2.18.5 Contractor shall require that its subcontractors comply with the Executive Order, and Contractor shall secure and maintain the required documents for City inspection.

  • Board Determination The Board of Directors of Pubco has unanimously determined that the terms of the Exchange are fair to and in the best interests of Pubco and its shareholders.

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