Development Failure definition

Development Failure means [* * *].
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Development Failure means the failure of Seller to perform one or more of those obligations under this Agreement that arise(s) out of or relate(s) to Seller’s obligations to design, develop, obtain permits for, interconnect, construct, test or complete the Project or the Electric System Upgrades, or any components thereof, including in connection with any obligation of Seller to deliver Product hereunder; provided that (1) Seller has used good faith efforts in performing its development obligations under this Agreement, and (2) such failure occurs prior to the Commercial Operation Date.
Sample 1
Development Failure shall have the meaning set forth in the Laredo License.
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Examples of Development Failure in a sentence

  • Any time period for the performance by the affected party of any duties and obligations under this Agreement, and any time period for the satisfaction or accomplishment of any condition, event, milestone or deadline, including, without limitation, those associated with a Development Failure, shall be extended for a period of time equal to the duration of the Force Majeure Event(s).

  • Summary Statistics of the First Licensing Agreements 52Table 9: Timing of Partnership Formation 53Table 10: The Impact of ODA on Licensing Propensity 54Table 11: Relationship between Licensing and Drug Approval 55Table 12: Relationship between Licensing and Development Failure 56Table 13: Chapter 3.

  • Conduct, rule 3-110(A)) By not filing the notice of appeal by June 3, 2004 and by not taking any steps to correct the untimely filing of the notice of appeal, respondent intentionally recklessly or repeatedly failed to perform legal services with competence.5Count 4(B): Failure to Inform Client of Significant Development Failure (Bus.

  • Product pipeline risks Research & Development Failure to meet development targets; difficulties of obtaining and maintaining regulatory approvals for new products; failure to obtain and enforce effective intellectual property protection; delay to new product launches; strategic alliances and acquisitions may be unsuccessful.

  • Josh Barro, DC’s Key Development Failure Isn’t Downtown, It’s Cleveland Park, FORBES (Apr.

  • Blueprint may terminate any individual Project Schedule upon: (i) thirty (30) days’ prior written notice to Ventana in the event of a Drug Development Failure, and (ii) thirty (30) days’ prior written notice at any time and for any (or no) reason.

  • Driving under the influence of alcohol on campus may result in, but is not limited to, the following sanctions.- The student’s car keys will be confiscated immediately.- The student must pay a cash fine of $100.00.- The student must participate in an alcohol program as specified by the Office of Student Development.- Failure to submit to an alcohol breath test will result in further disciplinary action.

  • Development Failure or Abortion IGNITE is still in the process of development, rather than a finished product ready to launch.

  • Product Development Manufacturing related :Development & Implementation of Process for Manufacture of LT & HT Cables in elimination of Voltage Process Development Failure during manufacture.Manufacturing of Segmental Conductor for higher sizes of Conductors for EHV cables.

  • Digital Textile Printing Systems Development Failure Modes Disintegrating System.


More Definitions of Development Failure

Development Failure means the Phase 2 Completion Date has not occurred by the Phase 2 Completion Date Deadline, as such may be extended pursuant to Section 4.10.
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Development Failure means one or more of the following: (a) Development Failure—Field Acquisition; (b) Development Failure—Test Well Funding; (c) Development Failure—UGD Permit Funding; (d) Development Failure—UGD Development Funding; and/or (e) Development Failure—UGD Development Funding Commitment.
Sample 1
Development Failure means Corium’s material, uncured failure to fulfill its development obligations under this Agreement.
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Related to Development Failure

  • Supply Failure shall have the meaning ascribed to it in Section 2.8.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Persistent Failure means any two (2) or more failures by the Supplier in any rolling period of twelve (12) months to comply with obligations in respect of the Contract Services under the Contract;

  • Consistent Failure means any of:

  • MI Failure means when an MI report: a) contains any material errors or material omissions or a missing mandatory field; or b) is submitted using an incorrect MI reporting Template; or c) is not submitted by the reporting date(including where a Nil Return should have been filed);

  • Service Failure means a failure by the Contractor to provide the Services in accordance with any individual service level described above (measured on a monthly/quarterly/annual basis)

  • Service Level Failure means a failure to perform the Software Support Services fully in compliance with the Support Service Level Requirements.

  • GEP Failure means Seller’s failure to produce Delivered Energy in an amount equal to or greater than the Guaranteed Energy Production amount for the applicable Performance Measurement Period.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Development Phase means the period before a vehicle type is type approved.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Epidemic Failure means a series of repeating failures or defects resulting in at least a 0.5% failure rate for the same Product or Material during any twelve-month period.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).