PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Competent Authority of any country in the Territory requests Strata to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall or withdrawal of the Product is contemplated by Strata (individually or collectively, a “Recall”), then Strata shall carry out any Recall in the Territory in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Strata shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Product in the Territory. Strata shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall for the period required by Applicable Law. Micrologix shall cooperate as reasonably requested by Strata in connection with any such Recall. Strata will be responsible for complying with all Applicable Laws and Governmental Approvals during the Recall and will be responsible for all interactions with appropriate Competent Authorities, including, the FDA Office of Compliance in the U.S. and the appropriate FDA local district office(s) in the U.S. Strata shall be responsible for preparing and timely submitting any reports any other documentation required by the Competent Authorities in connection with any such Recall.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Governmental Authority in the Territory requests a Party to recall a Product or if a voluntary recall of a Product is contemplated by either Party (collectively, a "Recall"), then the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Neither Party shall carry out a voluntary Recall in the Territory without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed by either Party. Any Recall in the Territory shall be carried out by CollaGenex in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. CollaGenex shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Products in the Territory. CollaGenex shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for the period required by Applicable Law.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any Jurisdiction requests a Party to recall the Product or if a voluntary recall of the Product is contemplated by either Party (collectively, a "Recall"), then the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Neither Party shall carry out a voluntary Recall in the Territory without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed by either Party. Any Recall in the Territory shall be carried out by Nycomed in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Nycomed shall in all events be responsible for conducting any Recall in the Territory, market withdrawals or corrections with respect to the Product in the Territory. Nycomed shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for the period required by Applicable Law. Acusphere shall be responsible, at its sole cost and expense, for conducting any Recall outside of the Territory and agrees to notify Nycomed immediately if a Competent Authority outside of the Territory has requested a Recall or if Acusphere is contemplating a voluntary Recall outside of the Territory; provided, however, that any such voluntary Recall shall be subject to Acusphere's contractual obligations with Third Parties outside the Territory and, if Acusphere is permitted to exercise discretion under such contractual obligations, Acusphere shall consider the effect of such voluntary recall on the marketing and sale of the Product in the Territory.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any country in the Territory requests either Party to recall the Product or if a voluntary recall is contemplated (a "Recall"), the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Neither Party shall carry out a voluntary Recall without the prior written approval of the other Party which approval shall not be unreasonably withheld, conditioned or delayed by either Party. Any Recall shall be carried out by Sanofi-Synthelabo in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Sanofi-Synthelabo shall in all events be responsible for conducting any Recalls, market withdrawals or corrections with respect to the Product. Sanofi-Synthelabo shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for the period required by Applicable Law.
PRODUCT RECALLS OR WITHDRAWAL. If either Party believes that a recall of any Product in the Territory is necessary, such Party shall immediately notify the other Party. Discovery shall retain sole authority and responsibility for determining whether a Product recall shall occur. Any
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any country requests either Party to recall the Product, or if a voluntary recall is contemplated (a "Recall"), the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party, it being understood and agreed that Genelabs shall have rights to initiate a recall if required by law. Any Recall in the Territory shall be carried out by Watsxx xx as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Unless otherwise required by law, Watsxx xxxll in all events be responsible for conducting any Recalls in the Territory, market withdrawals or corrections with respect to the Product in consultation with Genelabs. Watsxx xxxll maintain records of all sales and distribution of Product, as applicable, and customers sufficient to adequately administer a Recall, market withdrawal or correction for a period of five (5) years after the date the record is created.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time during the Term: (a) any Regulatory Authority of any country in the Territory requests MERCK to recall or withdraw the Product; (b) a court of competent jurisdiction issues an order or directive for the Product to be recalled or withdrawn; or (c) if a voluntary recall, withdrawal or correction of the Product is contemplated by MERCK (individually or collectively, a “Recall”), then MERCK shall carry out any Recall in the Territory. CARDIOME shall cooperate as reasonably requested by MERCK in connection with any such Recall. MERCK will be responsible for complying with all Applicable Laws and Regulatory Approvals during the Recall and will be responsible for all interactions with appropriate Regulatory Authorities. MERCK shall be responsible for preparing and timely submitting any reports and any other documentation required by the Regulatory Authorities in connection with any such Recall. MERCK shall be responsible for conducting any Recall of the Product in the Field in the Territory and the costs and expenses therefor shall be paid by MERCK. Each Party shall notify the other Party as soon as reasonably possible of any Recall of the Product initiated by such Party or any other Representative. For the avoidance of doubt, any non-publicly available information regarding any Recall shall be Confidential Information of MERCK.
PRODUCT RECALLS OR WITHDRAWAL. (a) In accordance with the terms of the Quality Agreement, if at any time any Regulatory Authority of any country requests a Party to recall the Product or if a voluntary recall of the Product is contemplated by either Party (collectively, a “Recall”), then the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Partner shall not carry out a voluntary Recall in the Territory without the prior written approval of PolyPid. Any Recall in the Territory shall be carried out by Partner in an expeditious as manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Partner shall in all events be responsible for conducting any Recall or market withdrawals with respect to the Product in the Territory. Partner shall maintain records of all sales and distribution of Product and customers sufficient to adequately administer a Recall or market withdrawal for the period required by Applicable Law. PolyPid shall be responsible for and shall maintain all records related to any corrections undertaken on the Product in the Territory. PolyPid agrees to notify Partner immediately if a Regulatory Authority outside of the Territory has requested a Recall or if PolyPid is contemplating a voluntary Recall outside of the Territory.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Competent Authority of any country in the Territory requests either Party to recall a Product, or if a voluntary recall is contemplated (a "Recall"), the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party. Geneva shall be responsible for conducting any Recalls, market withdrawals or corrections with the respect to a Product and shall make the final decision as to any voluntary Recalls after consultation with Atrix; provided that Atrix shall not be prohibited hereunder from taking any action that is required by law. Any Recall shall be carried out by Geneva in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of a Product and the goodwill and reputation of the Parties. Geneva shall maintain records of all sales and distribution of a Product and customers sufficient to adequately administer a Recall, market withdrawal or correction for a period of five (5) years after the date the record is created.
PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time to time any Governmental Authority of any country requests either Party or an Affiliate of either Party or a sublicensee of Schering to recall the Product, or if a voluntary recall is contemplated (a “Recall”), the Party to whom such request is made or the Party contemplating such Recall, as the case may be, shall immediately notify the other Party, it being understood and agreed that each Party shall have rights to initiate a recall if required by Applicable Laws. Any Recall in the Territory involving investigational clinical trial activities conducted by Sonus shall be carried out by Sonus in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Any other Recall in the Territory shall be carried out by Schering in as expeditious a manner as reasonably possible to preserve the goodwill and reputation of the Product and the goodwill and reputation of the Parties. Unless otherwise required by law, Schering shall in all events be responsible for conducting any Recalls in the Territory, market withdrawals or corrections with respect to the Product in consultation with Sonus. Schering or its designee shall maintain records of all sales and distribution of Product, as applicable, and customers sufficient to adequately administer a Recall, market withdrawal or correction for a period equal to the shelf-life of the Product plus one year after the date the record is created.
