GSK to Theravance Clause Examples

GSK to Theravance. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for the first Collaboration Product in which the Long-Acting â2 Adrenoceptor Agonist is [*], and for the first LABA/ICS Combination Product in which the Long-Acting â2 Adrenoceptor Agonist [*]: [*]* [*] [*]** [*] [*]** [*] [*] [*] Registration [*] [*] [*] [*] [*] [*] Launch [*] [*] [*] [*] [*] [*] Annual Worldwide Net Sales over [*] Collaboration Product [*] Annual Worldwide Net Sales over [*] Combination Product [*] * GSK will make a [*]. The [*] for [*] is defined as [*] and will [*]. The [*] is defined as [*] and will [*]. ** [*] is defined as [*] where such [*]. [*] is defined as [*]. Other Combination Products that contain a Long-Acting â2 Adrenoceptor Agonist that is a Theravance Compound are not subject to milestone payments by GSK only if [*]. The Parties intend that if the collaboration is successful [*] Collaboration Products that contain a Theravance Compound, Theravance be paid the applicable milestones [*]. If GSK, either individually or as a member of the Joint Steering Committee or Joint Project Committee, discontinues the Development of a [*] Collaboration Product that is a Theravance Compound for reasons other than [*], and such compound is the [*], it will [*]. [*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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GSK to Theravance. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for the first Collaboration Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is [***], and for the first LABA/ICS Combination Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is [***]: Initiation of Phase I * U.S.$10 Million Initiation of Phase IIa** U.S.$10 Million Initiation of Phase IIb** U.S.$5 Million [***] [***] [***] [***] [***] [***] Annual Worldwide Net Sales over [***] Collaboration Product [***] Annual Worldwide Net Sales over [***] Combination Product [***] * GSK will make a Phase I milestone payment for both TD-3327 and AMI-15471. The Phase I milestone for TD-3327 is defined as initiation of the methacholine challenge portion of the Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. The Phase I milestone for AMI-15471 is defined as initiation of the first Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. **Phase IIa is defined as initiation of the first single dose study in patients where such study is statistically powered for efficacy based on FEV1. Phase IIb is defined as initiation of the first four (4) week dosing, safety and efficacy study in patients. Other Combination Products that contain a Long-Acting x0 Xxxxxxxxxxxx Agonist that is a Theravance Compound are not subject to milestone payments by GSK only if [***]. The Parties ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. intend that if the collaboration is successful [***] Collaboration Products that contain a Theravance Compound, Theravance be paid the applicable milestones [***]. If GSK, either individually or as a member of the Joint Steering Committee or Joint Project Committee, discontinues the Development of a [***] Collaboration Product that is a Theravance Compound for reasons other than [***], and such compound is the [***], it will [***].
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GSK to Theravance. GSK shall make the following milestone payments to Theravance upon the achievement of the indicated Development Milestone for the first Collaboration Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is a Theravance Compound, and for the first LABA/ICS Combination Product in which the Long-Acting x0 Xxxxxxxxxxxx Agonist is a Theravance Compound: Initiation of Phase I * U.S.$10 Million Initiation of Phase IIa** U.S.$10 Million Initiation of Phase IIb** U.S.$5 Million Initiation of Phase III U.S.$25 Million U.S. U.S.$30 Million Europe U.S.$15 Million Japan U.S.$10 Million U.S. U.S.$30 Million Europe U.S.$15 Million Japan U.S.$10 Million Annual Worldwide Net Sales over U.S.$500 Million for single agent Collaboration Product U.S.$10 Million per year for first five years for single agent Collaboration Product Annual Worldwide Net Sales over U.S.$500 Million for LABA/ICS Combination Product U.S.$20 Million per year for first five years for LABA/ICS Combination Product * GSK will make a Phase I milestone payment for both TD-3327 and AMI-15471. The Phase I milestone for TD-3327 is defined as initiation of the methacholine challenge portion of the Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. The Phase I milestone for AMI-15471 is defined as initiation of the first Phase I Study in normal volunteers and will trigger a payment of U.S. $10 Million. **Phase IIa is defined as initiation of the first single dose study in patients where such study is statistically powered for efficacy based on FEV1. Phase IIb is defined as initiation of the first four (4) week dosing, safety and efficacy study in patients. Other Combination Products that contain a Long-Acting x0 Xxxxxxxxxxxx Agonist that is a Theravance Compound are not subject to milestone payments by GSK only if all milestone payments through launch have otherwise been made to Theravance from any Collaboration Product as both a single-agent and as a combination product. The Parties intend that if the collaboration is successful in launching at least two Collaboration Products that contain a Theravance Compound, Theravance be paid the applicable milestones through launch for two products. If GSK, either individually or as a member of the Joint Steering Committee or Joint Project Committee, discontinues the Development of a single agent Collaboration Product that is a Theravance Compound for reasons other than Technical Failure, and such compound is the LABA in a LABA/ICS Combi...
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