Withdrawals and Recalls. Bayer shall make all contacts with the relevant Regulatory Authority and shall be responsible for coordinating all activities in connection with any recall or withdrawal of any Product. In the event that Supplier believes a recall or withdrawal of a Product may be necessary or appropriate, Supplier shall promptly notify Bayer in writing. In the event that Bayer initiates a recall or withdrawal of a Product, Bayer shall promptly notify Supplier.
Withdrawals and Recalls. 6.1 In the event it is deemed necessary by either Company, in its discretion, or any of the Approved Suppliers, to withdraw or recall from Distributor and/or from the Restaurants any quantity of any Products (a) as a result of failure of such Products to satisfy the Company’s specifications as agreed upon by Company and the Approved Suppliers (b) for any other reason bearing on quality and/or safety of such Products, or (c) to prevent, minimize or otherwise protect against an actual or perceived threat to Company’s brand, Distributor shall comply diligently with all Product withdrawal/recall procedures in accordance with “Exhibit 6.1” “Product Withdrawals/ Recall”.
Withdrawals and Recalls. Talecris GmbH shall make all contacts with the relevant Regulatory Authorities and shall be responsible, at its sole cost and expense (except where the recall is due to the negligence or willful default of Xxxxx), for coordinating all activities in connection with any recall or withdrawal of any Contractual or Finished Product. In the event that Xxxxx believes a recall or withdrawal of a Contractual or Finished Product may be necessary or appropriate, Xxxxx shall immediately notify Talecris GmbH in writing. In the event that Talecris GmbH initiates a recall or withdrawal of a Contracutal or Finished Product, Talecris GmbH shall so notify Xxxxx. Notwithstanding the above, while Xxxxx remains the releaser of Finished Product:
Withdrawals and Recalls. 11.1. In the event it is deemed necessary by either the Company, in its discretion, or any of the Approved Suppliers, to withdraw or recall from Distributor and/or from the Company's System any quantity of any Products (a) as a result of failure of such Products to satisfy the Company's Specifications, (b) for any other reason bearing on quality and/or safety of such Products, or (c) to prevent, minimize or otherwise protect against an actual or perceived threat to the Company's brand, Distributor shall comply diligently with all Product withdrawal/recall procedures then in effect. See "Exhibit 11.1" "Product Withdrawals/ Recall".
Withdrawals and Recalls. Customer shall make all contacts with the relevant Regulatory Authority and shall be responsible for coordinating all activities in connection with any recall or withdrawal of any Products. In the event that Talecris believes a recall or withdrawal of any Cryo may be necessary or appropriate, Talecris shall promptly notify Customer in writing. In the event that Customer initiates a recall or withdrawal of any Products, Customer shall promptly notify Talecris. If Customer initiates a withdrawal or recall because the Cryo used in the manufacture of Products caused adverse reactions, then the cost of such withdrawal or recall shall be reimbursed by Talecris.
Withdrawals and Recalls. 4.10.1 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.
Withdrawals and Recalls. Distributors shall make all contacts with the relevant governmental Regulatory Authorities and shall be responsible for coordinating all activities in connection with any recall or withdrawal of any Product. In the event that a Releasor believes a recall or withdrawal of a Product may be necessary or appropriate, Releasor shall promptly notify the applicable Distributors and Newco (if it is not the Releasor) in writing. The Distributors shall consult with Newco prior to initiating any recall or withdrawal of any Product and, in the event that a Distributor initiates any recall or withdrawal of a Product, Distributor shall promptly so notify Newco. In the event of the discontinuance of B.Biologicals’ performance with respect to any Product pursuant to Section 12.6(b) of the Phase I Agreement, the applicable Distributors’ performance with respect to such Product pursuant to this Agreement shall also terminate.
Withdrawals and Recalls. (i) If any Regulatory Authority (A) threatens, initiates or advises any action to remove any Product from the market or (B) requires or advises Endo, BDSI, or any of their respective Affiliates to distribute a “Dear Doctor” letter or its equivalent regarding use of Product within *** (each, a “Regulatory Action”), then Endo or BDSI, as applicable, shall notify the other Party of such event within *** (or sooner if necessary to enable a Party to comply with applicable law) after such Party becomes aware of such Regulatory Action. Prior to the Closing Date, Endo shall have the right to decide whether to recall, withdraw or issue a field alert in connection with Product, and as between the Parties, Endo shall be responsible, at Endo’s sole expense, for conducting any recalls or withdrawals, issuing any field alerts, or taking such other necessary remedial action (each, a “Remedial Action”). On or after the Closing Date, BDSI shall have the right to decide whether to take any Remedial Action in connection with Product, and as between the Parties, BDSI shall be responsible for conducting any Remedial Action; provided, however, that, notwithstanding anything to the contrary herein, with respect to any Product sold by or on behalf of Endo or any Affiliate thereof prior to the Closing Date, Endo shall be entitled to effect (or to require BDSI to effect) any Remedial Action with respect thereto if Endo reasonably determines in good faith that such Regulatory Action is necessary or appropriate after providing BDSI a reasonable opportunity to do so and BDSI shall take all actions reasonably requested by Endo in connection therewith. FOIA CONFIDENTIAL TREATMENT REQUESTED BY BIODELIVERY SCIENCES INTERNATIONAL, INC. IRS EMPLOYER IDENTIFICATION NUMBER 00-0000000 ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “***”
Withdrawals and Recalls
