Recall, Withdrawal, or Market Notification of Product Sample Clauses

Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority suggests, threatens, recommends or initiates any action to remove the Product from the market whether in the Co-Commercialization Territory or in the COMPANY Territory (in whole or in part, including in clinical Trials), the Party receiving notice thereof shall notify the other Party of such communication promptly, but in no event later than [***], after receipt thereof. Notwithstanding the foregoing, in all cases MorphoSys shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Co-Commercialization Territory, and COMPANY shall determine whether to initiate any such recall, withdrawal or market notification of the Product in the COMPANY 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 MorphoSys or COMPANY (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 and each Party shall take the other Party’s comments under good faith consideration; further provided, that such discussions shall not delay any action that MorphoSys or COMPANY (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, MorphoSys or COMPANY (as the case may be) 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 reasonably necessary assistance, to conduct such recall, withdrawal or market notification. Without limiting the foregoing, each Party shall have the right to propose that a Product recall, withdrawal or market notification should be initiated by the other Party, but such other Party shall make the final decision whether the recall, withdrawal or market notification will be initiated in its respective Territory. Each Party shall at all times utilize a batch tracing system which will enable it to identify, on a prompt basis, customers within its Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers. Details of recalls’ management shall be dealt with in the Su...
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Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field in the Territory, Licensee shall notify Lilly of such communication promptly, [***] after receipt thereof. Licensee shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory. Licensee shall use [***] to utilize a batch tracing system that will enable Licensee 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 4.6. All costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product in the Field in the Territory shall be borne by Licensee.
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Recall, Withdrawal, or Market Notification of Product. In the event that (i) any Governmental Authority threatens or initiates any action to recall or withdraw the Product from the market, or to cause a market notification (e.g., by requiring the issuance of a “Dear Doctor” letter) or (ii) Licensee makes the determination to initiate any action to recall or withdraw the Product from the market, or to cause a market notification, Licensee shall notify Licensor of such communication or determination, as applicable, promptly and without delay after receipt or determination, as applicable, thereof. Licensee shall determine whether to initiate any recall, withdrawal or market notification of the Product. Licensee shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers who have been supplied with Product of any particular batch, and to recall such batch of Product from such customers as set forth in this Section 5.4. All costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product shall be borne by Licensee.
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Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market 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, any recall, withdrawal or market notification of the in the Territory shall be as set forth in the Quality Agreement.
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Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market whether inside the Licensee Territory or inside the OPKO Territory (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication immediately after receipt thereof. Notwithstanding the foregoing, if a Quality Agreement or Pharmacovigilance Agreement has been executed that applies to any recall, withdrawal or market notification of the Product in the Licensee Territory, then any such recall, withdrawal or market notification shall be conducted as set forth in the applicable agreement.
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Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market, Aimmune shall notify Xencor of such communication promptly, but in no event later than [***] ([***]) Business Days, after receipt thereof. Aimmune shall [***] any recall, withdrawal or market notification of the Product. As between the Parties, all costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product shall be borne by [***].
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Recall, Withdrawal, or Market Notification of Product 
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Related to Recall, Withdrawal, or Market Notification of Product

  • Withdrawal of Grievance A grievance may be withdrawn at any level without establishing a precedent.

  • Withdrawal of Bid Any bidder who makes a bid but withdraws same before the fall of the hammer, shall have their deposit equal to 10% of reserve price forfeited as agreed liquidated damages for payment to the Assignee. The Auctioneer reserves the right to put the property again for sale at the last undisputed bid, or otherwise to adjourn the auction to another date.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Withdrawal of General Partner (a) The General Partner may not Withdraw (other than as a result of an Involuntary Withdrawal) without the Consent of the Special Limited Partner. Withdrawal shall be conditioned upon the agreement of the Special Limited Partner to be admitted as a successor General Partner, or if the Special Limited Partner declines to be admitted as a successor General Partner then on the agreement of one or more Persons who satisfy the requirements of Section 13.5 of this Agreement to be admitted as successor General Partner(s).

  • Termination for Withdrawal of Authority Enterprise Services may suspend or terminate this Master Contract if, during the term hereof, Enterprise Services’ procurement authority is withdrawn, reduced, or limited such that Enterprise Services, in its judgment, would lack authority to enter into this Master Contract; Provided, however, that such suspension or termination for withdrawal of authority shall only be effective upon twenty (20) days prior written notice; and Provided further, that such suspension or termination for withdrawal of authority shall not relieve any Purchaser from payment for goods and/or services already ordered as of the effective date of such notice. Except as stated in this provision, in the event of such suspension or termination for withdrawal of authority, neither Enterprise Services nor any Purchaser shall have any obligation or liability to Contractor.

  • Withdrawal of Services 50.1 Notwithstanding anything contained in this Agreement, except as otherwise required by Applicable Law, Verizon may terminate its offering and/or provision of any Service under this Agreement upon thirty (30) days prior written notice to PNG.

  • Notice of Final Withdrawal Promptly after receipt by the Paying Agent of notice that the Escrow Agent has requested a Final Withdrawal or that a Final Withdrawal will be made, the Paying Agent shall cause notice of the distribution of the Final Withdrawal to be mailed to each of the Receiptholders at its address as it appears in the Register. Such notice shall be mailed not less than 15 days prior to the Final Withdrawal Date. Such notice shall set forth:

  • Withdrawal of a Member For purposes of this Agreement, a “Withdrawn Member” is a member who is bankrupt, has resigned, or has retired (a “Withdrawal Event”). Upon a Withdrawal Event, the Withdrawn Member or any successor in interest to the Withdrawn Member shall become an Assignee of the Withdrawn Member’s Membership Interest in the Company.

  • Recall Notification Notice of recall shall be sent to the bargaining unit member by certified mail. The City shall be deemed to have fulfilled its obligation by mailing the recall notice by certified mail, return receipt requested, to the last address provided by the bargaining unit member.

  • Application for Use a. The Employer agrees to accept properly executed leave applications within six (6) months of the first day of the period of leave being requested.

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