Biogen Territory. For the Biogen Territory, Biogen will have sole control over and decision-making authority with respect to the performance of Medical Affairs Activities in support of the Licensed Products.
Biogen Territory. Biogen will be responsible for one hundred percent (100%) of all costs and expenses incurred by or on behalf of Biogen in the performance of the Development of the Licensed Products solely for the Biogen Territory.
Biogen Territory. Biogen will use Commercially Reasonable Efforts to (a) Develop at least one Licensed 217 Product and at least one Licensed 324 Product in the Biogen Territory and (b) [**].
Biogen Territory. Biogen will use Commercially Reasonable Efforts to (a) obtain Pricing and Reimbursement Approval for a Licensed Product, where applicable, in each of the Major European Countries in which Regulatory Approval therefor has been obtained, and (b) following receipt of Pricing and Reimbursement Approval for a Licensed Product in any such Major European Country, where applicable, Commercialize such Licensed Product in each such country.
Biogen Territory. Biogen will have sole control over and decision-making authority with respect to the selection of the product name and Trademarks for use with all Licensed Products in the Biogen Territory. Biogen may elect to use any LP U.S. Trademark as the Trademark for the corresponding Licensed Product in the Biogen Territory, and if Sage is the owner of such LP U.S. Trademark, then Sage will and hereby does grant Biogen the exclusive right and license to use such LP U.S. Trademark in connection with the Commercialization of the applicable Licensed Product in the Biogen Territory. Biogen will register and maintain the LP U.S. Trademark in the Biogen Territory that it determines reasonably necessary in Sage’s name, at Biogen’s cost and expense.
Biogen Territory. Subject to Section 6.4 (Communications with Regulatory Authorities), Section 6.5 (Regulatory Meetings), Section 6.6 (Submissions), 6.8 (Right of Reference) and 6.9 (Recalls, Market Withdrawals or Corrective Actions), Biogen will have sole control and decision-making authority over all regulatory matters, including filing all Regulatory Materials, with respect to the Licensed Products in the Biogen Territory. Biogen will own, and may file in its name or the name of its designee, all Regulatory Materials with respect to the Licensed Products throughout the Biogen Territory. Starting on the Effective Date, Sage will [**] begin and [**] complete no later than [**] after the Effective Date, the assignment and transfer to Biogen of all Regulatory Materials related to any Licensed 217 Product or any Licensed 324 Product solely for the Biogen Territory, in each case, that are not necessary for Xxxx’s performance of the Ongoing 217 Studies or the KINETIC Study. Sage will provide reasonable and ongoing updates to Biogen regarding Sage’s process with respect to such transfer and assignment. Starting from the Effective Date and until [**] becomes the Regulatory Lead Party with respect to the Licensed 217 Products or Licensed 324 Products, as applicable, [**] will provide [**] with access to all Regulatory Materials relating to the Ongoing 217 Studies or the KINETIC Study, in each case, as may be required for [**] to conduct regulatory matters with respect to Licensed Products in the [**] Territory.
