Commercial Failure definition

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 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 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 [*].

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.

• In the event of Technical Failure or Commercial Failure or delay in the Commercial Launch Date for Compatible NIOBE-CARTO Systems (with relevant disposable products that customers can use therewith) beyond April 30, 2004 ("Delay"), Stereotaxis will have the right to place additional Stereotaxis Localization Systems (and proprietary localized disposable devices to be used therewith) in the manner set out in this Section 2.4.3.

• 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.

• 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.

• 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.

More Definitions of Commercial Failure

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 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 a Collaboration Product for reasons other than Technical Failure, based on the determination that such product will result in a net present value that is materially worse than the net present value for GSK’s other prescription pharmaceutical products, based on GSK’s normal and customary procedures for determining net present value for its own portfolio products. The net present value of a Collaboration Product will be based on forecasted cash flow from such product not taking into account the cannibalization of sales or profit from any other GSK product.

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.

Commercial Failure is understood to mean any circumstance that results in either a complete lack of exploitation or a material deterioration in the conditions of exploitation, for any reason whatsoever apart from technical reasons. The Beneficiary may request at any time that such failure be officially acknowledged. The Beneficiary shall submit any and all documentation proving such circumstance in order to substantiate its request. The Parties shall meet in order to assess the impact of such request on the marketing of the products resulting from the program and, if appropriate, shall amend the terms and conditions of the Financial Returns.