Regulatory Lead has the meaning set forth in Section 2.6.1.

Regulatory Lead means the Party specified as the “Regulatory Lead” in Section 4.4.1.

Regulatory Lead means, unless otherwise agreed by the Parties: [***] on a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term with respect to such Collaboration Target (if any), Sanofi for all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target.

Examples of Regulatory Lead in a sentence

In the event the Parties disagree concerning the form or content of a response, the Regulatory Lead will decide the appropriate form and content of it.
Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the Party will immediately provide to the other Party), the Regulatory Lead in the applicable Regulatory Jurisdiction will prepare the response to any observation that concerned this Agreement.
Except as mutually agreed, the other Party shall not take any other action in connection with any such Product Complaint without the consent of the Regulatory Lead.
The Regulatory Lead shall provide the other Party with reasonable advance notice of and any preparatory material for any hearing before, or meeting with, any Regulatory Authority in the Regulatory Lead's Regulatory Jurisdiction, and a reasonable number of representatives of the other Party shall have the right to attend such hearing or meeting.
The Regulatory Lead shall be exclusively responsible (with reasonable cooperation from the other Party as may be requested by the Regulatory Lead from time to time) for all post-approval updates to Regulatory Materials in its Regulatory Jurisdiction, such as annual updates, supplements and amendments and routine maintenance of the submissions of the Regulatory Materials that must be provided on the Product at periodic intervals to the Regulatory Authorities in its Regulatory Jurisdiction.

More Definitions of Regulatory Lead

Regulatory Lead has the meaning set forth in Section 5.2(a).

Regulatory Lead means, on a [***] basis and Regulatory Material-by-Regulatory Material basis, the Party having responsibility hereunder with respect to submission of, and communications with Regulatory Authorities regarding, such Regulatory Material. For clarity, [***].

Regulatory Lead means Takeda; except with respect to any Regulatory Submissions for the Ongoing Development Trials prior to the IND Transfer Date, for which Arrowhead will be the Regulatory Lead.

Regulatory Lead means, with respect to a country or regulatory region, the Party that has primary responsibility for preparing, obtaining and maintaining Regulatory Approvals for, and for conducting communications with the Regulatory Authorities with respect to, the Licensed Product in such country or region as provided in Section 2.4.

Regulatory Lead means the Party specified as the “Regulatory Lead” in Section 3.1.4(d)(iii) or Section 3.3.1 (Regulatory Lead).

Regulatory Lead means, [***].