Recalls etc. The Grantor agrees to handle the administration of, and be responsible for all costs and expenses relating to, all court actions, claims, governmental investigations or inquiries, recalls, stock recoveries or market withdrawals of the Product, including but not limited to, making all necessary and appropriate contacts with federal and state authorities, notifications to third parties, and Product disposition. The Grantor shall indemnify and hold the Secured Parties harmless from all claims, actions, losses, liabilities, damages and expenses arising from such matters, regardless of whether such claims, actions, losses, liabilities, damages and expenses relate to the period prior to or after the occurrence of an Event of Default.
Recalls etc. Any recalls, withdrawals, field alerts or similar actions involving the Product shall, as between the Parties, be controlled solely by Lannett; provided, however, that if Seller reasonably believes any such action may be necessary by virtue of any Product provided under this Agreement, Seller shall immediately notify Lannett in writing. Seller shall provide assistance to Lannett (and/or its designee), as reasonably requested by Lannett, in conducting such action, including providing all pertinent records that may assist Lannett in effecting such recall or other action. In the case of a recall, withdrawal, field alert or similar action involving the Product which is subject to indemnification by Seller under Section 6, Seller will reimburse the Lannett for any out-of-pocket cost reasonably expended by Lannett to effect the recall and the replacement of the Product without charge; provided, however, that in no event Seller will reimburse the out-of-pocket cost for the recalls resulting from the inappropriately stored or transported Product by Lannett in the storage condition other than what is provided by the Specification after the Product is delivered to Lannett. The losses caused by the recalls shall be incurred solely by the party that is responsible for the recalls and the losses shall be calculated according to the commercialization price of per unit multiplies the recall quantity of the Product.
Recalls etc. COULXXX xxxll notify BI PHARMA KG immediately by telephone and within 5 (five) working days in writing if any Product is the subject of a field alert, recall, market withdrawal or correction, and COULXXX xxx/or its designee shall have sole responsibility for the handling and disposition of such field alert, recall, market withdrawal or correction. *CONFIDENTIAL TREATMENT REQUESTED
Recalls etc. In the event that the FDA shall allege or prove that the drug of which the Product is the active ingredient does not comply with the rules and regulations of the FDA as a result of a breach of the warranties or covenants set forth in Section 7 of this Supply Agreement, Alteon will immediately notify Ganes and both parties shall cooperate fully regarding the investigation and disposition of any such matter. If Alteon shall be required or reasonably deems it appropriate to recall such drug and such recall is a consequence of any act or the negligence of, or breach of warranty or covenants by, Ganes and not of any act or negligence of Alteon, then in such event, Ganes will bear all reasonable direct costs associated with said 16 recall including, without limitation, replacement of the Product or refund of the price thereof and the actual cost of conducting the recall in accordance with FDA recall guidelines.
Recalls etc will use the Practice’s patient information, which may include its patient records, to compile a patient database that includes (as requested by the Practice) all or some of the following information: patient name, address, city, state, zip code, home telephone number, e-mail address, birth date, last examination date, insurance coverage, and diagnosis code. Recalls, Etc. will verify each patient’s address.
Recalls etc. By: Xx X. Xxxxxxx, President By: Name: Title: EXHIBIT A NOTICE OF PRIVACY PRACTICES1 (Name of Practice) THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
Recalls etc. Any recalls, withdrawals, field alerts or similar actions involving any of the Products listed in Exhibit A shall, as between the Parties, be controlled solely by Lannett; provided, however, that if Chartwell reasonably believes any such action may be necessary by virtue of any Products provided under this Agreement, Chartwell shall immediately notify Lannett in writing. Chartwell shall provide assistance to Lannett (and/or its designees), as reasonably requested by Lannett, in conducting such action, including providing all pertinent records that may assist Lannett in effecting such recall or other action. Chartwell shall be liable for such costs if a recall is the result of Chartwell’s negligence, error or omission.
