Example ContractsClausesRecalls, Suspensions or Withdrawals
Recalls, Suspensions or Withdrawals
Recalls, Suspensions or Withdrawals contract clause examples

Recalls, Suspensions or Withdrawals. Everest shall notify NPLH promptly following its determination that any event, incident or circumstance has occurred that would reasonably be expected to result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the Licensed Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Everest shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Licensed Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Everest shall consult with NPLH and shall consider NPLH’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Everest shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Laws. For all recalls, market suspensions or market withdrawals undertaken pursuant to this [Section 5.5] (Recalls, Suspensions or Withdrawals), as between the Parties, Everest shall be solely responsible for the execution thereof. Subject to ARTICLE 13 (Indemnification; Liability), Everest shall be responsible for all costs and expenses of any such recall, market suspension or market withdrawal.

In the event that any Regulatory Authority in the Territory threatens or initiates any action to remove a Product from the market (in whole or in part), the Party receiving notice thereof shall notify the other Party of such communication promptly, but in no event later than ​, after receipt thereof.

Product Withdrawals and Recalls. If any Regulatory Authority in the Territory # threatens, initiates or advises any action to remove any Product from the market or # requires or advises FibroGen China, AstraZeneca, or any of their respective Affiliates or Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product, then FibroGen

Recalls and Market Withdrawals. As between the Parties, [[Unknown Identifier]] shall have the sole right to determine whether to implement, and to implement, a recall, field alert, withdrawal or other corrective action related to the Product. [[Unknown Identifier]] shall bear the cost and expense of any such recall, field alert, withdrawal or other corrective action. Each Party shall promptly (but in any case, not later than ​ after) notify the other Party in writing of any order, request or directive of a court or other Governmental Authority to recall or withdraw the Product. BI shall reasonably cooperate with [[Unknown Identifier]] with any recall, field alert, withdrawal or other corrective action related to the Product by requiring that Oncology Personnel inform # prescribers of any such recall, field alert, withdrawal or corrective action, and # [[Unknown Identifier]] of any relevant information related thereto following such prescriber discussions.

Recalls and Withdrawals. In the event that any Regulatory Authority # threatens or initiates any action to recall or withdraw a Product from the market in any country in the Field in the Territory or # requires Licensee, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or a similar letter or notification regarding use of Product in the Field in the Territory, Licensee will notify MSD of such event within ​ Business Days after Licensee becomes aware of the action, threat, or requirement (as applicable). In all cases, Licensee will be responsible, at its sole expense, for conducting any recalls or withdrawals or taking such other necessary remedial action with respect to Product in the Field in the Territory.

Recalls and Market Withdrawals. As between the Parties, TYME shall have the sole right to determine whether to implement, and to implement, a recall, field alert, withdrawal or other corrective action related to the Product. TYME shall bear the cost and expense of any such recall, field alert, withdrawal or other corrective action. Each Party shall promptly (but in any case, not later than one (1) day after) notify the other Party in writing of any order, request or directive of a court or other Governmental Authority to recall or withdraw the Product.

Recalls and Voluntary Withdrawals. CANbridge will use ​ to notify LogicBio promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory. CANbridge will have the ​. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 4.1.6 (Recalls and Voluntary Withdrawals), CANbridge will be ​.

Recalls, Suspensions or Withdrawals. Licensee shall notify [[AstraZeneca:Organization]] promptly (but in no event later than 2 Business Days) following its determination that any event, incident or circumstance has occurred that Licensee has determined would result in the need for a recall, market suspension or market withdrawal of a Licensed Product in the Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, Licensee shall be solely responsible for handling any recall, market suspension or market withdrawal in the Field in the Territory at its sole cost and expense; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Licensee shall consult with [[AstraZeneca:Organization]] and shall consider [[AstraZeneca:Organization]]’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law.

Recalls, Suspensions or Withdrawals. Each Party shall notify the other Party promptly (but in no event later than ​) following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Licensed Product for use in the Licensed Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts. As between the Parties, PARTNER shall have the right to make the final determination of whether to voluntarily implement any such recall, market suspension or market withdrawal in the Licensed Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal in the [[Address A:Address]], PARTNER shall consult with REGENX and shall consider REGENX’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, PARTNER shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. Any costs and expenses incurred by the Parties in the event of any recall, market suspension or market withdrawal of a Licensed Product for use in the Licensed Field will be borne by the Parties as follows:

Recalls, Suspensions or Withdrawals. As between the Parties, Licensee shall be solely responsible for handling any recall, market suspension or market withdrawal in the Field in the Territory at its sole cost and expense; provided that prior to any implementation of such a recall, market suspension or market withdrawal, Licensee shall consult with [[AstraZeneca:Organization]] and shall consider [[AstraZeneca:Organization]]’s comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Licensee shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law.

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