Common use of Responsibility and Decision-Making Authority for Regulatory Affairs Clause in Contracts

Responsibility and Decision-Making Authority for Regulatory Affairs. Unless otherwise agreed in any definitive agreement executed by the Parties pursuant to Section 2.10, Licensee, at its own expense, shall have the sole right, responsibility and decision-making authority for all regulatory affairs in the Territory related to Licensed Product, including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to manufacture, or have manufactured, Licensed Product. Licensee shall file all such applications in its own name or that of its Affiliate. Licensee, at its own expense, shall have the sole right and responsibility for all communications and dealings with the Regulatory Authorities in the Territory.