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Wednesday, December 09, 2015 3:04:55 AM
product as Vitaros® in Germany, Luxemburg and Sweden and as Vytaros ® in Belgium. In July 2015, Sandoz reported that it was out of stock of Vitaros® in
Germany. Sandoz has put a hold on releasing additional batches pending the results of an ongoing out-of-specification investigation by the Company’s
contract manufacturer. Such investigation relates to a stability sample of Vitaros ® manufactured for sale in the United Kingdom (“U.K.”). All relevant health
authorities have been informed and are privy to the ongoing investigation. Sandoz continues to sell product in Sweden and Belgium and the Company’s
other Vitaros® partners continue to release batches and sell product in territories such as the U.K., France, Spain and Italy.m the 10Q
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