Recall Action. Subject to the Agreement, all coordination of any recall or field correction activities involving Company labeled Products shall be handled by Company, provided however that the Supplier shall at all times be informed of any such action involving the Company and the Products.
Recall Action. If CEPHALON should elect or be required to initiate a Product recall, withdrawal or field correction because of (i) supply by CATALYTICA of Product that does not conform to the Specifications and warranties established by this Agreement or (ii) the negligent or intentional wrongful act or omission of CATALYTICA, CEPHALON will notify CATALYTICA and provide CATALYTICA a copy of its recall letter prior to initiation of the recall. CATALYTICA will assist CEPHALON (and its designated Affiliate) in an investigation to determine the cause and extent of the problem. All regulatory authority contacts and coordination of any recall activities will be initiated by, and will be the sole responsibility of, CEPHALON.
Recall Action. (a) In the event Sagent should be required or should voluntarily decide to initiate a recall, Product withdrawal, or field correction of any Products in the Territory pursuant to this Agreement, Sagent through its designee shall notify Gland and provide a copy of its proposal, including the recall letter, for review prior to initiation of such action, and shall consult with Gland prior to initiation of such action; provided, however, that Sagent shall not be prohibited hereunder from taking any action that it is required to take by applicable law. In conjunction with such recall, Gland shall assist in the investigation to determine the cause and extent of the problem.
(b) In the event that Gland independently believes that a recall, Product withdrawal, or field correction for Products may be necessary or appropriate, Gland shall notify Sagent through Sagent’s designee of Gland’s belief, and the parties shall fully cooperate with each other concerning the necessity and nature of such action.
Recall Action. If CEPHALON should elect or be required to initiate a -------------- Product recall, withdrawal or field correction because of (i) supply by CIRCA of Product that does not conform to the Specifications and warranties established by this Agreement or (ii) the negligent or intentional wrongful act or omission of CIRCA, CEPHALON will notify CIRCA and provide a copy of its recall letter prior to initiation of the recall. CIRCA will assist CEPHALON (and its designated Affiliate) in any investigation to determine the cause and extent of the problem. All regulatory authority contacts and coordination of any recall activities will be initiated by CEPHALON.
Recall Action. If PURCHASER should elect or be required to initiate a Product recall, withdrawal or field correction because of (i) supply by [MANUFACTURER] of Product that does not conform to the Specifications and warranties established by this Agreement or (ii) the negligent or intentional wrongful act or omission of [MANUFACTURER], PURCHASER will notify [MANUFACTURER] and provide [MANUFACTURER] a copy of its recall letter prior to initiation of the recall. [MANUFACTURER] will assist PURCHASER (and its designated Affiliate) in an investigation to determine the cause and extent of the problem. All regulatory authority contacts and coordination of any recall activities will be initiated by, and will be the sole responsibility of, PURCHASER.
Recall Action. If Indevus should elect or be required to initiate a recall, withdrawal, stock recovery or field correction (each, or collectively, a “Recall”) of API or product containing API because of supply by Helsinn of API that does not conform to the Specifications and warranties established by this Agreement, subject in any case to Section 14.1 hereunder, Indevus will notify Helsinn and provide Helsinn a copy of its recall letter prior to initiation of the recall. Helsinn will assist Indevus (and its designee) in an investigation to determine the cause and extent of the problem. All regulatory authority contacts and coordination of any recall activities will be initiated by, and will be the sole responsibility of, Indevus.
Recall Action. (i) In the event Allegiance should be required or should voluntarily decide to initiate a recall, Product withdrawal, or field correction of any of the Products, Allegiance shall notify Isolyser and provide a copy of its recall letter. In conjunction with such recall, Isolyser and MedSurg shall assist in the investigation to determine the cause and extent of the problem and the parties shall fully cooperate with each other concerning the necessity and nature of such action.
(ii) In the event that Isolyser independently believes that a recall, Product withdrawal or field of correction for any of the Products may be necessary or appropriate, Isolyser shall notify Allegiance of Isolyser's belief, and the parties shall fully cooperate with each other concerning the necessity and nature of such action.
(iii) All coordination of any recall or field correction activities involving any of the Products shall be handled by Allegiance whether or not such action was initially requested by Isolyser.
(iv) In the event that any Product is recalled as a result of the supply by Isolyser or MedSurg of Product that does not conform to Specifications and/or the warranties set forth in Section 11 of this Agreement or the negligent or intentionally wrongful act or omission of Isolyser or MedSurg or their representatives, then, Isolyser shall bear all of the reasonable costs and expenses of such recall, including without limitation, expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers.
Recall Action. 6.4.1 In the event Teva / Sicor is required or voluntarily decides to initiate a recall, withdrawal, or field correction of the Product, Teva / Sicor shall notify Antares and provide a copy of its proposal, including the recall letter. In conjunction with such recall, Antares at Teva / Sicor’s sole expense shall assist in the investigation to determine the cause and extent of the problem, unless it is subsequently determined that such recall was necessitated entirely by the negligence or intentionally wrongful act of Antares or its representatives, in which case such assistance shall be at Antares’ sole expense. **** - Denotes portions omitted pursuant to an amended request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission.
6.4.2 In the event that Antares independently believes that a recall, withdrawal, or field correction of the Product may be necessary or appropriate, Antares shall notify Teva / Sicor of Antares’ belief, and the Parties shall fully cooperate with each other concerning the necessity and nature of such action, provided that, in the event that the Product is recalled as a result of the negligent or intentionally wrongful act of Teva / Sicor or its representatives, any expenses incurred by Antares in connection with such cooperation, including, but not limited to, outside expert fees and reasonable legal fees, shall be borne by Teva / Sicor.
6.4.3 All coordination of any recall, withdrawal or field correction activities involving the Product shall he handled by Teva / Sicor, who shall keep Antares promptly advised of all matters relating thereto, whether or not such action was initially requested by Antares. Unless required by applicable law or regulation, or unless due to a defect in the Device, Teva / Sicor will not disclose or refer to Antares in connection with a recall, withdrawal or field correction without Antares’ prior written consent.
Recall Action. 6.2.1 In the event Skye is required or voluntarily decides to initiate a recall, withdrawal, or field correction of the Product, Skye shall notify Enzon and provide a copy of its proposal, including the recall letter, for review prior to initiation of such action and the Parties shall fully consult and cooperate with each other concerning the need for such a recall and in order to develop and execute a recall plan, as necessary. In conjunction with such recall, Enzon shall assist, at Skye’s sole discretion and expense, in the investigation to determine the cause and extent of the problem.
6.2.2 In the event that Enzon independently believes that a recall, withdrawal, or field correction of the Product may be necessary or appropriate, Enzon shall notify Skye of Enzon’s belief, and the Parties shall fully cooperate with each other concerning the necessity and nature of such action.
6.2.3 All coordination of any recall or field correction activities involving Product shall be handled by Skye, in cooperation with Enzon, whether or not such action was initially requested by Enzon.
Recall Action. Following notification of a recall, within forty-eight (48) hours, the parties' representatives from business, medical, regulatory, quality assurance and legal functions (and any others deemed necessary by a party) shall discuss whether or not to conduct a recall (except in the case of a government-mandated recall), and if so, the timing of the recall, the breadth, extent and level of customer to which the recall shall reach, the strategies and notifications to be used, and other related issues. Nothing in this Section 6 shall prohibit either party from taking action required to comply with applicable law.
