JSC Approval. The JSC shall approve the overall strategy and positioning of all material Regulatory Materials (including product labeling) prior to their submission or filing, based upon reasonably detailed reports and summaries of such submissions and filings presented to the JSC by the Responsible Party. In connection with such review, the Responsible Party shall promptly provide to the JSC such additional information regarding a proposed filing as the Participating Party may reasonably request.
Appears in 3 contracts
Samples: Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Cephalon Inc)
JSC Approval. The JSC shall approve the overall strategy and positioning of all material Regulatory Materials (including product labeling) prior to their submission or filing, based upon reasonably detailed reports and summaries of such submissions and filings presented to the JSC by the Responsible PartyCollaborator. In connection with such review, the Responsible Party Collaborator shall promptly provide to the JSC DWG such additional information regarding a proposed filing as the Participating Party MSB may reasonably request.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Mesoblast LTD)