Commercial Failure definition

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.

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 [***].

Examples of Commercial Failure in a sentence

• In the event of a Commercial Failure, either Party shall have the right to terminate this Agreement upon ** prior written notice to the other Party; provided, however, that Onconova shall not have a right to terminate this Agreement pursuant to this Section 15.2.5 if such Commercial Failure results, directly or indirectly, from the failure of Onconova or its Affiliates or agents to supply Product under the Supply Agreement if executed pursuant to Section 8.1.

• It is recognised that success can be optimised by pursuing a number of Collaboration Products through various phases of clinical Development up to the point of Technical or Commercial Failure, and/or until the first Collaboration Product for both single agent and combination therapy achieves regulatory agency approval.

• Any time following the third anniversary of the Effective Date, either Party may terminate this Agreement, subject to Section 14.10, upon the provision of ninety (90) days written notice if Development of all Collaboration Products and all Pooled Compounds have been discontinued for Technical Failure and/or Commercial Failure.

• In the case of Technical Failure, Commercial Failure or Delay, Biosense will have the right to act as sole distributor of such additional Stereotaxis Localization Systems (and proprietary electrophysiological localized disposable devices to be used therewith), based on reasonable commercial terms to be mutually agreed upon by Biosense and Stereotaxis.

• In the event of Technical Failure or Commercial Failure or other termination as referred to in Section 14.2.3, Stereotaxis will have the right to grant up to 500 licenses to third parties under its Localization License having terms ending no later than three (3) years following the date of such Technical Failure or Commercial Failure in order to enable Stereotaxis to secure access to an alternative catheter based Localization system that is compatible with the Stereotaxis NIOBE System.

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, with respect to the Technology, a reasonable, good faith determination that a material change has occurred in market conditions for the Technology (including a determination by patent counsel to Parent or the Surviving Corporation that a third party issued patent or a third party pending patent application, if issued, would be infringed by the practice of some or all of the Company IP to make, have made, use or sell the Technology in the United States, or other substantial freedom to operation restrictions on the practice of some or all of the Company IP to make, have made, use or sell the Technology in the United States) that was not reasonably anticipated by Parent as of the Effective Date and that makes further development or commercialization of the Technology commercially unreasonable to pursue.

Commercial Failure means, with respect to any OCT System or OCT Product, a reasonable determination that a material change has occurred in market conditions for such OCT System or OCT Product that was not reasonably anticipated by Parent as of the Effective Date and that makes further development or commercialization of such OCT System or OCT Product commercially unreasonable to pursue.

Commercial Failure will have occurred (i) if the sales of Daughter Products at any time following the first anniversary of the Commercial Launch Date are at an aggregate run rate of less than one catheter month Compatible NIOBE-CARTO System, provided that Compatible NIOBE Systems sold for less than $450,000 will be excluded from such calculation; (ii) the Compatible CARTO Installation Ratio is less than 25%; or (iii) Stereotaxis' installed base of Compatible NIOBE Systems comprises less than 25% of the Stereotaxis' forecast provided to Biosense in a letter of even date herewith.