Common use of Research and Studies Clause in Contracts

Research and Studies. Licensee shall not conduct basic research or pre-clinical, clinical or other studies (including Clinical Trials, non-clinical toxicology studies or any other study in humans or animals) with the Compound or Licensed Product without Shionogi's prior written approval (which may be provided or withheld in Shionogi's sole discretion). For the avoidance of doubt, Shionogi shall have the right to review the study design, specifications, protocol and related materials of any such proposed studies. In the event that any such studies have been approved by Shionogi, Licensee will pay for any necessary supplies, and Licensee agrees to fully comply with all Applicable Law in connection with such Clinical Trials. Unless specified otherwise in a writing signed by Shionogi, Shionogi will not be the sponsor or hold regulatory responsibility for such Clinical Trials and Licensee, pursuant to Section 9.3(a), shall indemnify Shionogi for any liability arising, directly or indirectly, from or based on the conduct of any Clinical Trial or study. Without limiting the foregoing, in the event Shionogi approves any such studies or trials in accordance with this Section 3.3, then, at the option of Shionogi, Shionogi may, but shall have no obligation to, have its representative review any approved studies, but in no event will such activities relieve the sponsor of such Clinical Trials from their oversight and monitoring obligations.

Research and Studies. Licensee shall not conduct basic research or pre-clinical, clinical or other studies (including Clinical Trials, non-clinical toxicology studies or any other study in humans or animals) with the Compound or Licensed Product without Shionogi's prior written approval (which may be provided or withheld in Shionogi's sole discretion). For the avoidance of doubt, Shionogi shall have the right to review the study design, specifications, protocol and related materials of any such proposed studies. In the event that any such studies have been approved by Shionogi, Licensee will pay for any necessary supplies, and Licensee agrees to fully comply with all Applicable Law in connection with such Clinical Trials. Unless specified otherwise in a writing signed by Shionogi, Shionogi will not be the sponsor or hold regulatory responsibility for such Clinical Trials and Licensee, pursuant to Section 9.3(a), shall indemnify Shionogi for any liability arising, directly or indirectly, from or based on the conduct of any Clinical Trial or study. Without limiting the foregoing, in the event Shionogi approves any such studies or trials in accordance with this Section 3.3, then, at the option of Shionogi, Shionogi may, but shall have no obligation to, have its representative review any approved studies, but in no event will such activities relieve the sponsor of such Clinical Trials from their oversight and monitoring obligationsmonitoringobligations.