Drug Experience Reports Sample Clauses

Drug Experience Reports. Oread shall give Praecis prompt written notice of any information Oread receives regarding the safety of the Product, including any confirmed or unconfirmed information on adverse, serious or unexpected events associated with the use of the Product. For serious, unexpected events, immediate telephonic notice must be given by Oread to Praecis, and written notice must be given by Oread to Praecis within three (3) business days, after receipt of the information. For all other such information, written notice must be given by Oread within fifteen (15) business days after receipt of the information. Praecis shall send Oread copies of all priority submissions and periodic reports relating to the Product sent to the FDA within five (5) business days of the submission to the FDA. All responsibility and cost for filing any reports with the regulatory authorities concerning such reactions (including Drug Experience Reports) caused by Product manufactured for Praecis shall be borne by Praecis. Praecis will be responsible at its cost for handling Product complaints. Oread will provide assistance in responding to any complaints including reviews of retained samples and Batch Records as well as testing of Products engendering a complaint and retained samples if required. The costs of such testing shall be borne by Praecis. However, if it is determined that the Product complaint was directly or indirectly caused by Oread's failure to Process and Package in accordance with the Master Batch Record or if the Product complaint is related to the Product's failure to conform to any of the Specifications at the time of the Oread Approval Date, Oread shall reimburse Praecis for the reasonable actual costs of such testing.
Sample 1
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Related to Drug Experience Reports

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