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. 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. (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.
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. If NABRIVA should elect or be required to initiate a recall of pharmaceutical product containing or manufactured using API supplied hereunder, or a withdrawal or field correction of such pharmaceutical product, HOVIONE shall assist NABRIVA (and/or its Affiliate(s)) in connection with such recall, withdrawal, or field correction, including, without limitation, by conducting an investigation to determine the extent to which the API contributed to the need for such recall, withdrawal, or field correction. All regulatory authority contacts and coordination of any recall activities shall be initiated by, and shall be the sole responsibility of, NABRIVA.
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.
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.
Recall Action. All Product recalls and FDA contacts relating to ------------- recall of Products in the United States or elsewhere in the world with respect to Products sold by EPI will be the responsibility and under the control of EPI; all Product recalls and regulatory authority contacts relating to recall of Exempted Products sold by DMPC in Exempt Territories will be the responsibility and under the control of DMPC. Each party agrees to contact the other as soon as practicable after deliberations have begun regarding the potential recall of a Product manufactured at either of the Facilities. Either party has the right to initiate a Product recall, withdrawal or field correction. If either party should decide or be required to initiate a Product recall, withdrawal or field correction, that party will provide the other a copy of its recall letter for prior approval which shall not unreasonably be withheld.
