Common use of Regulatory Coordination Clause in Contracts

Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions (including supplements and amendments thereto) to each applicable Regulatory Authority with respect to the VEGF Product in the jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article 7. The Lead Regulatory Party shall perform all such activities in accordance with the Co-Development Plans, Global Co-Commercialization Plans, applicable Country Co-Commercialization Plans, and all applicable Laws.

Appears in 2 contracts

Samples: Collaboration Agreement, Collaboration Agreement (Regeneron Pharmaceuticals Inc)

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Regulatory Coordination. (ai) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions (including of supplements and amendments thereto) , to each applicable Regulatory Authority with respect to the VEGF Product in the jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article 7each Product. The Lead Regulatory Party shall perform all such activities in accordance with the CoJoint Steering Committee-approved Development PlansPlan, Global Co-Commercialization Plans, applicable relevant Country Co-Commercialization Plans, Plans and all applicable Lawspricing strategies and guidelines.

Appears in 2 contracts

Samples: License and Commercialization Agreement (Idenix Pharmaceuticals Inc), License and Commercialization Agreement (Idenix Pharmaceuticals Inc)

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Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions (submissions, including supplements and amendments thereto) to , to, each applicable Regulatory Authority with respect to the VEGF IL-1 Product in the jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article 7. The Lead Regulatory Party shall perform all such activities in accordance with the Joint Steering Committee-approved Consolidated Co-Development Plans, Global Plans and Consolidated Co-Commercialization Plans, applicable Country Co-Commercialization Plans, and all applicable Laws.

Appears in 1 contract

Samples: Collaboration, License and Option Agreement (Regeneron Pharmaceuticals Inc)

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