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

Alnylam shall be the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter.
Celgene shall be the Development Lead Party, the Commercialization Lead Party and the Regulatory Lead Party in the ROW Territory.
If any Regulatory Authority requires the Regulatory Lead to have the ability to institute recalls unilaterally in a particular Regulatory Jurisdiction, then the Regulatory Lead shall have such right.
The Regulatory Lead shall consider in good faith the Non-Regulatory Lead’s comments and use reasonable efforts to implement such comments.
Subject to Section 6.12, on a Collaboration Target-by-Collaboration Target basis, the Regulatory Lead will be solely responsible for all regulatory matters in the Territory relating to the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead.

More Definitions of 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, 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, [***].

Regulatory Lead has the meaning set forth in Section 5.1 (General).

Regulatory Lead means [***].