definiens: efforts shall mean those efforts expended by [COMPANY] on its own high priority projects . [COMPANY] shall prepare in collaboration with [COMPANY] all documentation necessary for associated filings with regulatory agencies and [COMPANY] shall make all such filings as described in Exhibit B. However, [COMPANY] may, in its sole discretion, determine to have [COMPANY] make filings for Regulatory Approval . The JOC will oversee clinical development and regulatory filings and carry out plans for clinical development and regulatory filings communicated to it by [COMPANY] . Exhibit B sets forth the Clinical Trials to be conducted, along with the anticipated timeline, requirements and estimated costs for the Clinical Trials and associated regulatory filings . If there are changes in project scope, time lines or costs, the JOC shall be informed and shall review and suggest necessary changes or additions . [COMPANY] shall make all final decisions on any changes or additions to Exhibit B