Lead Regulatory Party definition

Lead Regulatory Party has the meaning set forth in Section 4.1.

Lead Regulatory Party means, with respect to a country or region, the Party with the main responsibility for carrying out regulatory activities in accordance with Section 5.

Lead Regulatory Party means the Party having responsibility for preparing, prosecuting and maintaining Registration Filings and any Approvals for Licensed Products in the Field under this Agreement, and for related regulatory duties.

Examples of Lead Regulatory Party in a sentence

• The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.

• The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder.

• The Parties agree that if a clinical trial is necessary for one market only (i.e., a confirmatory study), then the Lead Regulatory Party with such market in its territory shall be responsible for such clinical trial.

• The Lead Regulatory Party shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions.

• The Lead Regulatory Party shall also be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities in its territory with respect to a Collaboration Product.

More Definitions of Lead Regulatory Party

Lead Regulatory Party means, for a given Program, the POC Lead Regulatory Party or the Merck Participation Term Lead Regulatory Party, as applicable. 1.183 [***]

Lead Regulatory Party has the meaning set forth in Section 9.1.

Lead Regulatory Party means, with respect to each VEGF Product, whichever of (and to the extent) Aventis or Regeneron has been designated hereunder as having responsibility for preparing, prosecuting and maintaining Approvals and Registration Filings relating to such VEGF Product, and for related regulatory duties.

Lead Regulatory Party shall have the meaning set forth in Section 7.1(a).

Lead Regulatory Party or “LRP” means, with respect to each particular stage of Development of a Development Candidate or Product Candidate in the applicable Development Region or Commercialization Territory, as the case may be, the Party designated as the lead Regulatory Party therefor pursuant to Section 4.3(e), 4.4(d), 5.5(a)(vii), 5.5(b)(iii), 5.5(d)(iv), 5.6(a)(iv), 5.6(b)(ii), or 5.6(d)(iv).

Lead Regulatory Party means, with respect to each IL-1 Product, whichever of Novartis or Regeneron has been designated hereunder as having responsibility for preparing, prosecuting and maintaining Approvals and Registration Filings relating to such IL-1 Product, and for related regulatory duties.

Lead Regulatory Party means the Party so assigned pursuant to this Section 5.2, with the rights and responsibilities set forth under Section 5.4. The Party that is not the Lead Regulatory Party shall be the “Supporting Regulatory Party”. Genentech shall be the Lead Regulatory Party with respect to all Collaboration Products for all Indications, other than with respect to (a) the Ongoing Clinical Studies, any Melanoma Follow-Up Study permitted pursuant to Section 4.3.2(a), and (b) any BioNTech Study Conducted under [***]