Development Governance Clause Samples
The DEVELOPMENT GOVERNANCE clause establishes the framework and procedures for overseeing and managing the progress of a development project. It typically outlines the roles and responsibilities of key stakeholders, sets up regular reporting or review meetings, and may specify decision-making protocols for addressing issues or changes during the project. By providing clear guidelines for project oversight, this clause helps ensure accountability, timely communication, and effective resolution of challenges, ultimately supporting the successful completion of the development work.
Development Governance. (a) For Licensed Products under development pursuant to a Development Plan, BioMarin shall exclusively manage the development of Licensed Products under the supervision of the Steering Committee, until the Completion of Phase II.
(b) For Licensed Products under development pursuant to a Development Plan, following Completion of Phase II for a Licensed Product for an Indication, upon formation of the Development Team, the Development Team shall manage the day-to-day development of such Licensed Product based upon the Development Plan. Each Development Plan shall allocate functional management of each activity under the Development Plan to the Parties with due regard for each Party’s legitimate concerns and interests as well as the completion of the Development Plan as a whole.
(c) Upon Regulatory Approval of a Licensed Product for an Indication by both the FDA and the EMEA, all further development, including any post marketing approvals required by a Regulatory Agency, shall be exclusively managed in the Territory by Serono and shall be exclusively managed outside the Territory by BioMarin. Notwithstanding the foregoing, the Parties will endeavor in good faith to coordinate any overlapping post marketing commitments and to equitably allocate any expenses.
Development Governance. 17 3.1 Clinical Development Trials for Hemophilia Type B ............. 17 (a) Clinical Development Activities ...................... 17 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Development Governance. 3.1 CLINICAL DEVELOPMENT TRIALS FOR HEMOPHILIA TYPE B.
(a) CLINICAL DEVELOPMENT ACTIVITIES.
(i) AVIGEN. Avigen shall, at [...*...] and [...*...] with the Legal Requirements, use [...*...] in compliance with the recommendation of any Regulatory Agency [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Development Governance