Common use of Additional Indications Clause in Contracts

Additional Indications. Maruho may, at any time, suggest to JDC new indications to develop for Japan for discussion purpose. The JDC shall reasonably consider such additional indications in accordance with the principles set out in Section 6.1 below. [***]. Once the new indication is approved by the JDC, this indication will become an integral part of Upstream’s development plan for execution using reasonable development efforts and JDC shall discuss and decide reasonable timeline in advance of commencement of such development. If Upstream fails to initiate clinical trials in the new indication within [***] after the target date for initiation of such clinical trial agreed by the JDC, Upstream shall present to the JDC a detailed explanation for the delay and specify the actions it is taking to expedite development and further discuss with ▇▇▇▇▇▇ whether to delegate the right to continue to develop the Product on its own in that indication in Japan. If Upstream fails to submit a CTN of clinical trials in the new indication within [***] after the target date for submission of a CTN of such clinical trial agreed by the JDC, ▇▇▇▇▇▇ will have the right to continue to develop the drug on its own in that indication in Japan, in consultation with and with reasonable support of Upstream.