BTG Israel and BTG U Sample Clauses

BTG Israel and BTG U. S. shall each give the other prompt notice of any information either of them receives regarding the safety of the Raw Materials or Product, including any confirmed or unconfirmed information on adverse, serious or unexpected events associated with the use of the Product. For serious or unexpected events, notice must be given by telephone within one (1) business day after receipt of the information and followed by written notice not less than one (1) week thereafter. All responsibility, including responses due and cost for filing any reports with the FDA or other Regulatory Authorities concerning such reactions (including Drug Experience Reports) caused by the Product manufactured for BTG U.S. shall be BTG U.S.'s. Further to the above, BTG U.S. will be responsible at its cost for handling Product complaints involving commercial goods which contain Product. BTG Israel will provide timely assistance in responding to any complaints including reviews of Batch records and retained samples as well as testing of Product engendering a complaint if required, and BTG U.S. will reimburse BTG Israel for reasonable expense incurred therewith. The costs of such testing shall be borne by BTG U.S.; however, if it is determined that the Product complaint was directly or indirectly caused by BTG Israel's failure to Process the Product in accordance with the Specifications, BTG Israel shall reimburse BTG U.S. for the actual and reasonable costs of such testing and other Claims arising therefrom.
Sample 1
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