Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. BI shall be responsible for the completion of all administrative and regulatory procedures required for the continued Development and Commercialization of the Products, according to the provisions of the Research Plan and Master Development Plan(s). BI shall be solely responsible for the submission of applications for Regulatory Approvals for Products and for seeking Regulatory Approvals for Products in the Territory and all submissions for Regulatory Approvals shall be made in the name of BI, its Affiliates, Sublicensees or Recognized Agents and any and all documents, data, and other information submitted by BI, its Affiliates, Sublicensees or Recognized Agents, including but not limited to, the drug master file and the dossier shall be and remain the exclusive property of BI, without limitation on the provisions of this Agreement concerning the Data Room but subject to the Parties’ rights on termination of this Agreement or the Development or Commercialization of any Product. BI shall be responsible for all pharmacovigilance activities relating to the Products.

Regulatory Submissions. BI shall be responsible for the completion complete n of all administrative and regulatory procedures required for the continued Development and Commercialization of the Products, according to the provisions of the Research Plan and Master Development Plan(s)Plan. BI shall be solely responsible for the submission of applications for Regulatory Approvals for Products and for seeking Regulatory Approvals for Products in the Territory and all submissions for Regulatory Approvals shall be made in the name of BI, its Affiliates, Sublicensees or Recognized Agents and any and all documents, data, and other information submitted by BI, its Affiliates, Sublicensees or Recognized Agents, including but not limited to, the drug master file and the dossier shall be and remain the exclusive property of BI, without limitation on the provisions of this Agreement concerning the Data Room but subject to the Parties’ rights on termination of this Agreement or the Development or Commercialization of any Product. BI shall be responsible for all pharmacovigilance activities relating to the Products.