Common use of Development; Regulatory Activities and Approvals Clause in Contracts

Development; Regulatory Activities and Approvals. (a) PII shall use Diligent Efforts and be responsible for the conduct of the Development of the Compound and the Licensed Product(s) within the Territory in order to obtain and maintain Regulatory Approval of a [*] (“Major Regulatory Filings”) for a Licensed Product for the Indication as promptly as practicable. In executing the Development Plan, PII shall be solely responsible for all costs and expenses relating to the Development Plan and obtaining Regulatory Approval for the Licensed Product(s). Without limiting the generality of the foregoing, PII shall be responsible for the preparation, filing and prosecution of all agency applications for obtaining Regulatory Approvals in the Territory which are required to commercially sell or use the Licensed Product(s) in the Territory and for all subsequent related submissions. All Regulatory Documentation and Regulatory Approvals in the Territory shall be owned and filed in the name of PII. PII shall use Diligent Efforts in preparing the Major Regulatory Filings for Regulatory Approval of the Licensed Product(s) and in causing such agency applications to progress through the Regulatory Approval process. PII shall use Diligent Efforts for the preparation and submission of all governmental and agency applications for Regulatory Approval for a Licensed Product for the Indication in countries of the Territory other than [*] (which are addressed separately above) in which PII determines to submit agency applications, and the receipt of such Regulatory Approvals, including, without limitation, pricing and reimbursement approval, where applicable. (b) If PII receives a written communication from a Regulatory Agency, either directly or through a sublicensee or a Third Party Partner of PII, relating to the Compound or the Licensed Product(s) which relate to the Development, marketing, safety or efficacy of the Compound or the Licensed Products, and which would materially affect the time for receipt of Regulatory Approval of such Licensed Product(s) or the ability of PII to Develop or market such Licensed Product(s), PII shall promptly provide RBX’s Alliance Manager (as provided in Section 4.02(a)) with a summary of such information. Such summary shall be subject to the confidentiality obligations of Article IX hereof.