Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. (a) Telix (or its designated Affiliates, contractors or sublicensees) will prepare, submit and hold all Applications for Regulatory Approval for the Licensed Product in the Field in the Territory. (b) Telix (or its designated Affiliates, contractors or sublicensees) will be responsible for interactions with Regulatory Authorities in the Territory with respect to the Licensed Product in the Field and will bear related expenses. (c) Telix will be responsible for obtaining Regulatory Approvals for development, use, and Commercialization of the Licensed Product from the Regulatory Authorities in the Territory and will use Commercially Reasonable Efforts to obtain such approvals. Telix will pay or cause the payment of all costs and expenses necessary to obtain such approvals, including all costs of human clinical trials and all costs of drafting and filing Applications for Regulatory Approval in the Territory. (d) As between the Parties, the development and commercialization of the Licensed Product in the Field to be conducted under the terms and conditions of this Agreement shall be under sole control of Telix.