Common use of Within the Territory Clause in Contracts

Within the Territory. UP shall solely manage all applications, requests for authorization, submissions of Information and data and for all interactions with the FDA or applicable governing health authority for the purpose of attempting to obtain registration of the Products within the Territory in accordance with the Initial Assessment Period or the UP Development Program. UP shall have the final authority to make all clinical and regulatory decisions with respect to the registration of Products within the Territory in its sole reasonable discretion. UP shall provide AltaRex with sufficient time to review and approve all material submissions of Information and data prior to submission to the FDA or applicable governing health authority, and AltaRex shall participate and collaborate in the process of Product registration including, without limitation, participation in meetings with regulatory authorities and interaction with UP staff, contractors and consultants on a regular basis regarding the development and commercialization of Products. UP shall solely and exclusively own all regulatory applications, approvals, clinical data and Product registrations obtained by UP or its Affiliates with respect to Products within the Territory, including retaining control and ownership of each Drug Master File related to the Licensed Technology within the Territory. For the avoidance of doubt, the foregoing materials shall be deemed to be Data.