Recall of Licensed Product. In the event that any Regulatory Authority in the Territory issues or requests a recall or takes similar action in connection with the Licensed Compound or any Licensed Product or in the event Licensee determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, Licensee shall use Commercially Reasonable Efforts to, within [***] inform Licensor by telephone (and confirm by email) or email. Following any such notification in respect of the Territory, Licensee shall decide whether to conduct a recall (except in the case of a government-mandated recall) and the manner in which any such recall shall be conducted. In the event that any Regulatory Authority outside the Territory issues or requests a recall or takes similar action in connection with the Licensed Compound or Licensed Product or in the event Licensor determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal outside the Territory, Licensor shall use Commercially Reasonable Efforts to, within [***] inform Licensee by telephone (and confirm by email or facsimile), email or facsimile. Following any such notification in respect of outside the Territory, Licensor shall decide whether to conduct a recall (except in the case of a government-mandated recall) and the manner in which any such recall shall be conducted. The Party primarily responsible for causing a recall shall bear the expenses of that recall of the Licensed Compound or the Licensed Product.
Recall of Licensed Product. For any Licensed Product, in the event that (i) any governmental agency or authority issues a request or directive or order that Licensed Product be recalled or retrieved; (ii) a court of competent jurisdiction orders that Licensed Product be recalled or retrieved; or (iii) Cypress or any of its sub-licensees reasonably determines, after reasonable, good faith discussion with Xxxxxx Xxxxx, that Licensed Product should be recalled or retrieved, Cypress shall promptly notify Xxxxxx Xxxxx of such event and shall conduct such activity and take appropriate corrective actions, and Xxxxxx Xxxxx shall provide such assistance to Cypress and its sub-licensees as is reasonably necessary to carry out such activities. All reasonable costs and expenses of such recall and corrective actions shall be the responsibility of Cypress or its sub-licensees, provided that Xxxxxx Xxxxx shall indemnify Cypress and its sub-licensees for such cost and expense in accordance with Section 9.2 below.
Recall of Licensed Product. In the event either party believes a recall, field alert, product withdrawal or field correction may be necessary with respect to Licensed Product supplied under this Agreement, such party shall immediately notify the other party in writing. NovaDel will not act to initiate a recall, field alert, product withdrawal or field correction without the express prior written approval of BioAlliance, unless otherwise required by applicable law, and each party shall provide all necessary cooperation and assistance to the other party with respect thereto. BioAlliance shall be responsible for any such recall, field alert, product withdrawal or field correction of Licensed Product in the Territory; provided, however, that the cost of any recall, field alert, product withdrawal or field correction shall be borne by BioAlliance, except to the extent such recall, field alert, product withdrawal or field correction is caused by NovaDel’s breach of its warranties, representations or obligations under this *** Portion for which confidential treatment requested.
Recall of Licensed Product. For any Licensed Product, in the event that: (a) any Regulatory Authority in the Territory issues a request, directive or order that the Licensed Product be recalled or retrieved; (b) a court of competent jurisdiction in the Territory orders that the Licensed Product be recalled or retrieved; or (c) one Party reasonably determines, after reasonable, good faith discussion with the other Party to the extent that time allows, that the Licensed Product should be recalled or retrieved, then first Party shall promptly notify the other Party of such event. STA shall conduct such activity and take appropriate corrective actions, and PUMA shall provide such assistance to PUMA as is reasonably necessary to carry out such activities. All reasonable costs and expenses of such recall and corrective actions shall be borne entirely by STA, except that PUMA shall bear any such costs and expenses that arise out of PUMA’s breach of this Supply [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Agreement, to the extent that such breach by PUMA is not caused by STA’s failure to perform its obligations under this Supply Agreement.
Recall of Licensed Product
