Regulatory Activities definition

Regulatory Activities means all activities relating to the obtaining and maintaining of any Regulatory Approval with respect to a Licensed Product, including without limitation, the preparation and filing of Regulatory Filings and interacting with Regulatory Authorities with respect to such Regulatory Filings.

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.

Regulatory Activities has the meaning set forth in Section 2.2.

Examples of Regulatory Activities in a sentence

• With respect to Licensed Adjuvanted Products, Sanofi shall have the exclusive right to conduct Regulatory Activities, be the Regulatory Responsible Party for, and file for and obtain Marketing Authorization in its sole discretion at its own cost and expense, within the scope of the Adjuvant License and subject to other restrictions applicable to Sanofi as set forth in Article 2 (License Grants; Exclusivity) and in this Article 4 (Regulatory).

• Each Party may propose amendments to the Regulatory Transfer Plan through the JSC at any time to reflect any material adjustments to the applicable Regulatory Activities described therein, which amendments will be subject to review, discussion, and determination whether to approve in accordance with Article 9 (Governance).

• With respect to the Licensed COVID-19 Mono Products, during the Collaboration Term, the Parties agree to (a) conduct Regulatory Activities in accordance with the COVID-19 Research and Development Plan and this Article 4 (Regulatory) and (b) transition to Sanofi the responsibility for all Regulatory Activities in accordance with the Regulatory Transfer Plan as further set forth in this Article 4 (Regulatory).

• Novavax shall have the exclusive right to conduct Regulatory Activities, be the Regulatory Responsible Party for, and file for and obtain Marketing Authorization in its sole discretion at its own cost and expense, for Novavax Adjuvant Products.

• Neither Party shall conduct Regulatory Activities other than as set forth in the COVID-19 Research and Development Plan, the Regulatory Transfer Plan, or this Article 4 (Regulatory).

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 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 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.

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.