Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, Licensee shall conduct all regulatory activities related to Development and Commercialization activities in its own or the Designated Parties’ name for Licensor, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Licensee shall be responsible for all of its costs and expenses in connection with obtaining and maintaining Regulatory Approvals for Products in the Territory.

Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, as between Licensee shall conduct all regulatory activities related to Development and Commercialization activities in its own or the Designated Parties’ name for Licensor, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Licensee shall be solely responsible for all of its costs and expenses in connection with obtaining and maintaining Regulatory Approvals regulatory matters for Licensed Products in the Field in the Territory, including preparing and filing any and all regulatory materials for each Licensed Product, at its sole expense.

Regulatory Responsibilities. Subject to (a) As between the terms and conditions of this AgreementParties, Licensee shall conduct will be solely responsible for all regulatory submissions and exchanges and will direct and control all regulatory activities related to Development and Commercialization activities in its own or the Designated Parties’ name for Licensor, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Licensee shall be responsible for all of its costs Compounds and expenses in connection with obtaining and maintaining Regulatory Approvals for Products in the Territory, including responses and correspondence, safety reporting, negotiation, analysis, and strategy. Licensor will provide timely and appropriate support to Licensee with respect to such regulatory activities [***] and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in Licensor’s possession or under Licensor’s Control related to any Compound or Product to Licensee.