Launch Sequence. No later than [***] following the Effective Date, Licensee will prepare a list of those countries in the Territory in which Licensee intends to commence Commercialization of each Licensed Product within the first [***] after receipt of Regulatory Approval for such Licensed Product from the FDA and the EMA and timelines reflecting potential date ranges for First Commercial Sale following receipt of Regulatory Approval and Reimbursement Approval (if applicable) in such countries, (the “Launch Sequence” and the countries included in the Launch Sequence, the “Launch Countries”). Licensee will amend or update the Launch Sequence [***] thereafter, including updating such sequence with additional countries in the Territory in which Licensee plans to commence Commercialization of a Licensed Product. The Launch Sequence and all amendments and updates thereto will be [***] by the JCC pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and subsequently [***] by the JSC pursuant to Section 3.1.5(n) (Specific Responsibilities of the JSC); provided that if the JSC is unable to [***] the Launch Sequence or any amendment or update thereto, then such matter will not be referred for resolution by the Executive Officers, and instead Licensee’s representatives on the JSC will [***] the Launch Sequence (including the Launch Countries).
Launch Sequence. No later than [**] following Licensee’s submission of the MAA for the Licensed Product to the EMA, Licensee will prepare and submit to the JSC for its review and discussion a list of those countries in the Territory in which Licensee intends to Commercialize the Licensed Product and timelines reflecting the target date of the First Commercial Sale (the “Launch Sequence”, and the countries included in the Launch Sequence, the “Launch Countries”). Licensee will amend or update the Launch Sequence at least [**] thereafter, including updating such sequence so as to provide reasonable prior notice of the target date of the First Commercial Sale in any additional countries in the Territory not included in the initial Launch Sequence. Each amendment and update to the Launch Sequence will be reviewed and discussed by the JSC pursuant to Section 3.4 (Specific Responsibilities of the JSC).
Launch Sequence. A list of those countries in the Territory in which Licensee intends to commence Commercialization of the Licensed Product within the first [**] after the Effective Date and timelines reflecting potential date ranges for First Commercial Sale following receipt of Regulatory Approval and Reimbursement Approval (if applicable) in such countries, (the “Launch Sequence” and the countries included in the Launch Sequence, the “Launch Countries”) is made part of this Agreement in Schedule 7.2.1. Licensee will amend or update the Launch Sequence [**] thereafter (without formally amending this Agreement), including updating such sequence with additional countries in the Territory in which Licensee plans to commence Commercialization of the Licensed Product. The Launch Sequence and all amendments and updates thereto will be reviewed and discussed by the JSC.
