Commercial Failure means (a) the failure of the Licensed Product to meet the specifications for the Licensed Product as set forth in Schedule 1.13(a) and/or the failure of the Licensed Product to meet other criteria for the Licensed Product identified in the Development Plan, including meeting clinical endpoints, in each case if such failure materially and adversely alters the ability to develop the Licensed Product as contemplated by the Development Plan or to commercialize the Licensed Product, (b) an issue involving safety, toxicity, efficacy, or pharmacokinetics of the Licensed Product that materially and adversely alters the development of the Licensed Product as contemplated by the Development Plan or commercialization of such Licensed Product, (c) determination by an independent expert that it is not technically feasible to scale up manufacturing for a Licensed Product to a production lot size that is consistent with what is required to continuously meeting the Licensed Territory demands for the applicable Licensed Product throughout the Term, (d) a regulatory requirement comes into effect after the Effective Date that would materially and adversely alter the development of a Licensed Product as contemplated by the Development Plan or commercialization of such Licensed Product or (e) the failure of Licensed Product to achieve at least ** of projected Net Sales, as set forth in Schedule 1.13(e), in the Licensed Territory for any calendar year following ** after receipt of Marketing Approval for the Licensed Product in the European Union.
Commercial Failure means failure of a Collaboration Product for reasons other than Technical Failure, based on the determination that such product will result in a [***] that is materially worse than the [***], based on GSK’s normal and customary procedures for determining [***]. The [***] of a Collaboration Product will be based on [***] from such product not taking into account the [***].
Commercial Failure means failure of an Alliance Product for reasons other than Technical Failure, based on the determination that such product will result in [*] that is materially worse than [*] based on GSK's normal and customary procedures for determining [*]. The [*] of an Alliance Product will be based on [*] from such product not taking into account [*]. [*]=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.
Examples of Commercial Failure in a sentence
Notwithstanding the foregoing, if BAXTER terminates the AGREEMENT under Section 19.2 due to a COMMERCIAL FAILURE, the TERMINATION FEE [***].
More Definitions of Commercial Failure
Commercial Failure means the circumstances under which the quarterly Net Sales of the Product decline by [Redacted]*; provided, however that such decline is not caused by (i) a significant change in market conditions (including, without limitation, the introduction of a Competing Product by a Third Person or governmentally-mandated price reductions), (ii) change of existing laws or regulations, or adoption of new laws or regulations, (iii) Force Majeure Events, (iv) safety and efficacy reasons as reasonably determined by the Steering Committee after discussion with the appropriate regulatory authority, (v) change of marketing strategy (including, without limitation, a reduction of price) approved by the Steering Committee, and (vi) availability of Product.
Commercial Failure means the circumstances under which the quarterly Net Sales of Product decline by [Redacted]* on a Regulatory Jurisdiction per Regulatory Jurisdiction basis; provided, however that such decline is not caused by (i) a significant change in market conditions (including, without limitation, governmentally-mandated price reductions or launch by a Third Person of a Competing Product or other product targeting any gonadotropin, gonadotropin receptor or gonadal steroid associated disease or condition), (ii) change of existing laws or regulations, or adoption of new laws or regulations, (iii) Force Majeure Events, (iv) safety and efficacy reasons as reasonably determined by SB after discussion with the appropriate regulatory authority, (v) change of marketing strategy (including without limitation a reduction of price) and/or (vi) availability of Product.
Commercial Failure means that Vyera fails to achieve aggregate [***].
Commercial Failure means failure of [*] for reasons other than [*], based on the determination that such product will result in a [*] that is materially worse than the [*]. The [*] of a [*] will be based on [*] from such product not taking into account the [*].
Commercial Failure means: (i) [***], as defined by the RESEARCH COMMITTEE; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***]; (vi) [***]. For clarity, if the AGREEMENT is terminated by BAXTER in part under Section 19.2(iii) due to a COMMERCIAL FAILURE, there shall be [***].” [***] indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Commercial Failure means, with respect to any Company Product, that a material change has occurred in market conditions for such Company Product that was not reasonably anticipated by Parent as of the Effective Date and that renders it commercially unreasonable for Parent or the Surviving Corporation or any DPD Buyer or Acquiring Entity, as applicable, to pursue development or commercialization of such Company Product using Commercially Reasonable Efforts. For purposes of this definition, any elimination of reimbursement, or material reduction in the reimbursement rate, associated with the Current Procedural Terminology coding covering any Company Product published by the American Medical Association, the Healthcare Common Procedure Coding System codes covering any Company Product published by the Centers for Medicare & Medicaid Services, or any similar or successor coding systems, shall be deemed a material change.
Commercial Failure means, with respect to PRO-515, a reasonable determination that a material adverse change has occurred in market conditions for PRO-515 that was not reasonably anticipated by Parent as of the Effective Date and that makes further development or commercialization of PRO-515 commercially unreasonable to pursue.