Specific Milestones. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for each of the first single agent Alliance Product and the first Combination Alliance Product per Alliance Program: Initiation of [*]* [*] Successful completion of [*]** (where [*] means [*] for a Validated Target and [*] for a Non-Validated Target, as such Validated/Non-Validated Targets will have been agreed by the Parties pursuant to Section 4.1.4). [*] Initiation of [*] [*] Filing for Regulatory Approval [*] [*] [*] [*] [*] [*] Launch [*] [*] [*] [*] [*] [*] * [*] milestone is only payable for Theravance Compounds from Discovery Programs for which GSK has given notice of its wish to exercise its Opt-In Right prior to initiation of a [*] for the first Theravance Compound in such Discovery Program. ** [*] milestone is only payable for Theravance Compounds from Discovery Programs for which GSK has given notice of its wish to exercise its Opt-In Right prior to initiation of a [*] for the first Theravance Compound in such Discovery Program. For the purpose of this Section 6.2, the following definitions shall apply: "Initiation of [*]" means [*] for the applicable Alliance Product "Successful completion of [*]" means [*] conducted in the target population for the applicable Alliance Product. "Initiation of [*]" means [*] for the applicable Alliance Product.
Appears in 3 contracts
Samples: Strategic Alliance Agreement (Theravance Inc), Strategic Alliance Agreement (Theravance Inc), Strategic Alliance Agreement (Theravance Inc)
Specific Milestones. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for each of the first single agent Alliance Product and the first Combination Alliance Product per Alliance Program: Initiation of [*]a Phase I Study* [*] U.S.$3 Million Successful completion of [*]a Phase II Study** (where [*] means [*] for a Validated Target and [*] for a Non-Validated Target, as such Validated/Non-Validated Targets will have been agreed by the Parties pursuant to Section 4.1.4). [*] U.S.$10 Million Initiation of [*] [*] Filing for Regulatory Approval a Phase III Study U.S.$25 Million [*] [*] [*] [*] [*] [*] Launch [*] [*] [*] [*] [*] [*] * [*] Phase I milestone is only payable for Theravance Compounds from Discovery Programs for which GSK has given notice of its wish to exercise its Opt-In Right prior to initiation of a [*] Phase I Study for the first Theravance Compound in such Discovery Program. ** [*] Phase II milestone is only payable for Theravance Compounds from Discovery Programs for which GSK has given notice of its wish to exercise its Opt-In Right prior to initiation of a [*] Phase II Study for the first Theravance Compound in such Discovery Program. For the purpose of this Section 6.2, the following definitions shall apply: "“Initiation of [*]" ” means [*] for the applicable Alliance Product "“Successful completion of [*]" ” means [*] conducted in the target population for the applicable Alliance Product. "“Initiation of [*]" ” means [*] for the applicable Alliance Product.
Appears in 1 contract