Development-Related Responsibilities Sample Clauses
The Development-Related Responsibilities clause defines the specific duties and obligations of each party involved in a development project, such as software creation, construction, or product design. It typically outlines who is responsible for tasks like project management, resource allocation, milestone achievement, and compliance with relevant standards or regulations. By clearly assigning these responsibilities, the clause helps prevent misunderstandings, ensures accountability, and facilitates smooth project execution.
Development-Related Responsibilities. The JSC shall coordinate, liaise, review and discuss matters related to the Development of the Product in the Territory, the Reserved Territory and the Global Studies to be undertaken in accordance with this Agreement. Without limitation to the generality of the foregoing, it shall prepare and approve annual (or, if needed, more frequent) updates and revisions to the Development Register, will discuss and attempt to resolve disagreements escalated by any subcommittees or project teams that may be set up from time to time to discuss any specific issues in relation to Development and assume such other responsibilities as are set forth in this Agreement, or as mutually agreed in writing by duly authorized representatives of the Parties from time to time.
Development-Related Responsibilities. The JDCC shall be responsible for: (i) confirming and preparing annual (or, if needed, more frequent) updates and revisions to the Development Plan for the Territory prepared jointly by the Parties pursuant to Section 5.1; (ii) monitoring activities and progress under the Development Plan; (iii) overseeing the maintenance of all Marketing Authorizations in the Territory, including the performance of post-approval commitments in the Territory; (iv) overseeing the sharing of regulatory correspondence and other regulatory information, and overseeing planning and submissions for Marketing Authorizations in the Territory that are filed after the Effective Date; (v) subject to Article 5, overseeing further medical and development work for the Product in the Territory, including development of the Product for any New Indication or in any New Formulation as may be mutually agreed by the Parties; (vi) subject to Article 5, overseeing clinical trials, investigator-initiated trials, post-hoc data analyses, and sponsored research arrangements for the Territory; (vii) overseeing pharmacovigilance activities for the Territory; (viii) overseeing medical affairs activities for the Territory; (ix) developing a publication strategy in the Territory and review procedures for such publications; (x) attempting to resolve disagreements escalated by any subcommittees or project teams; and (xi) assuming such other responsibilities as are set forth in this Agreement, or as mutually agreed in writing by duly authorized representatives of the Parties from time to time.