Examples of Regulatory Filings in a sentence
Licensee shall consider in good faith any comments received from Zenas on such Regulatory Filings.
Licensee shall be responsible for all costs and expenses of preparing, coordinating, maintaining, formatting, and filing Regulatory Filings for the Products in the Territory and for maintaining Regulatory Approval for the Products in the Territory.
Subject to, and in accordance with, the terms and conditions of this Agreement, the requirements of all Applicable Laws and the relevant Development Plan, Licensee shall prepare and file all Regulatory Filings required to Develop the Compound and Products and, if successful, to obtain and maintain Regulatory Approvals of the Products in the Field in the Territory.
Licensee shall provide to Zenas for review and comment drafts of all material Regulatory Filings in English language in the Territory for the Products no later than [***] prior to the planned submission.
Each Development Plan shall set forth an estimated timeline and details of all major Development activities to be conducted by or on behalf of Licensee for the Products in the Field in the Territory for that Development Plan, as well as the plans and estimated timeline for preparing and filing the necessary Regulatory Filings and for obtaining Regulatory Approval of the Products in the Territory.