Regulatory Activities definition
Regulatory Activities means all regulatory activities (such as filing, pricing, reimbursement, inspection by Regulatory Authorities) in order to obtain and to maintain Product Approval(s) for the Product in the Territory.
Regulatory Activities has the meaning set forth in Section 2.5.1.
Regulatory Activities means any and all actions reasonably necessary or required to obtain or maintain the Regulatory Approvals, including, without limitation, the design and conduct of clinical trials as necessary.
Examples of Regulatory Activities in a sentence
KalVista may perform the Regulatory Activities itself or through any other Third Party designee, provided that KalVista will require that such Third Party designee perform the Regulatory Activities that they are engaged to perform in compliance with this Agreement and Applicable Law in the Territory.
Notwithstanding the engagement of such Third Party designee, KalVista will remain primarily liable to Kaken for the performance of all of the Regulatory Activities hereunder.
More Definitions of Regulatory Activities
Regulatory Activities mean any one or more of the regulatory activities to be performed by Hana, its Licensees, Sublicensees, or their respective Representatives in pursuit of the Development of each Product, including writing, translation, compilation, notification, submission, filing, defense, maintenance and renewal of Regulatory Approvals and payment of fees associated therewith, and meeting with Regulatory Authorities.
Regulatory Activities means any regulatory activities directed towards compiling, filing and obtaining any Regulatory Approval for a Licensed Product in the Partner Territory including completion of any sample testing required by Regulatory Authorities for a Licensed Product in the Partner Territory.
Regulatory Activities means with respect to the Licensed Product in the Territory: (a) the preparation, review, filing and maintenance of any and all Regulatory Filings; (b) maintaining contact and communication with KFDA, MHW, HIRA and/or all other applicable Governmental Bodies; and (c) otherwise complying with all requirements of a holder of any Regulatory Approval and applicable Law.
Regulatory Activities means any and all regulatory affairs related to (a) Development (including MAA pre-submission meetings with EMA, meetings and discussions with rapporteurs or co-rapporteurs and other regulatory affairs activities directed to obtaining Regulatory Approvals of Products), including interactions with Regulatory Authorities regarding Regulatory Approvals and other Regulatory Filings and (b) Commercialization, including Pricing or Reimbursement Approval, including interactions with Pricing Authorities.
Regulatory Activities means with respect to a Product, Elected Additional Products or New Presentation: (a) the preparation, review and filing of any and all Regulatory Filings; (b) maintaining contact and communication with the Regulatory Authorities; and (c) otherwise complying with all requirements of a Sponsor and applicable Laws. For the avoidance of doubt, Regulatory Activities include any NPS Program activities and compassionate use program activity.
Regulatory Activities has the meaning set forth in Section 7.3(b).
Regulatory Activities means all activities, other than Development and Commercialization activities, that are reasonably necessary in order to obtain and maintain Regulatory Approval of Product in the Field in the Territory, including but not limited to (a) the preparation, filing, and maintenance of Regulatory Materials, including the filing of annual updates, and (b) the conduct of post-marketing Studies.