Development Regulatory Activities Clause Samples
The DEVELOPMENT / REGULATORY ACTIVITIES clause outlines the responsibilities and procedures related to the development of a product and the actions required to obtain and maintain regulatory approvals. It typically specifies which party is responsible for conducting research, preparing regulatory submissions, and interacting with regulatory authorities, as well as how information and updates are shared between parties. This clause ensures that both parties understand their roles in navigating regulatory requirements, thereby facilitating efficient product development and compliance with applicable laws.
Development Regulatory Activities. ViroPharma shall be solely responsible for seeking and obtaining Regulatory Approval from Regulatory Authorities to perform activities under the Development Plan and Budget, including, without limitation, filing any INDs and submitting protocols to such INDs as approved by the JSC as necessary. ViroPharma shall use commercially reasonable efforts to extend the VP Product Exclusivity Period for each VP Product. Within twenty (20) days after submission to FDA, ViroPharma shall provide Aventis with copies of all material final submissions to such INDs for studies performed under the Development Plan and Budget. Consistent with Laws, up to three (3) Aventis representatives shall be permitted to attend all meetings and conferences with any Regulatory Authority in the Territory concerning VP Compounds or VP Products.
Development Regulatory Activities