Technical Product Failure definition

Technical Product Failure means (a) a [*] of a Collaboration Compound or Product under Development or Commercialization under this Agreement, as determined (i) by a consensus decision by the China Committee or the JSC (if the China Committee cannot reach consensus) or (ii) following referral of the matter to the Executive Officers pursuant to Section 2.2(e) and Section 2.6(c) of the U.S. and RoW Agreement, by a consensus decision by the Executive Officers, or (iii) in the event that a consensus decision by the Executive Officers has not been attained within twenty (20) Business Days after the JSC’s submission of the matter to them, by expedited resolution in accordance with Section 14.8; or (b) a Regulatory Authority action or decision [*].
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Technical Product Failure means (a) a [ * ] of a Collaboration Compound or Product under Development or Commercialization under this Agreement, as determined (including following a review of the Carcinogenicity Studies) (i) by a consensus decision by the JSC or (ii), following referral of the matter to the Executive Officers pursuant to Section 2.6(c), by a consensus decision by the Executive Officers, or (iii), in the event that a consensus decision by the Executive Officers has not been attained within twenty (20) Business Days after the JSC’s submission of the matter to them, by expedited resolution in accordance with Section 14.8; or (b) a Regulatory Authority action or decision [ * ].
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Technical Product Failure means as a [ * ], which is not attributed to Astellas’ failure to fulfill its obligations hereunder.
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Examples of Technical Product Failure in a sentence

  • Disputes related to whether or not a Technical Product Failure has occurred will be resolved in accordance with Section 14.8.

  • Upon termination of this Agreement pursuant to Section 13.3 for a Technical Product Failure, all licenses and rights to the FibroGen Technology granted to AstraZeneca under Article 7 shall terminate and, to the extent appropriate given the nature of the Technical Product Failure and subject to applicable law, including GCP, the other termination consequences set out in Sections 13.6(a) through 13.6(g) as well as Section 13.6(j) shall apply.

  • MaherTitle: Senior Vice President,General Counsel and SecretaryDated: August 1, 2001Exhibit 2.1 TERMINATION AGREEMENT dated as of July 27, 2001, by and among UAL CORPORATION, a Delaware corporation ("UAL"), YELLOW JACKET ACQUISITION CORP., a Delaware corporation ("Yellow Jacket"),and US AIRWAYS GROUP, INC., a Delaware corporation ("US Airways").

  • The Industry Expert’s determination shall be binding as to whether a Technical Product Failure has occurred, and such determination shall be given retroactive effect.

  • Technical Product Failure, this Agreement and the obligations hereunder shall continue until the actual termination of this Agreement, and in the event that this agreement terminates due to such Technical Product Failure and Astellas has made any Upfront Payment(s) between the date of such notice and the date of termination, FibroGen shall [ * ].

  • Technical Product Failure (subject to the provisions regarding timing of termination in the event of a dispute below), immediately upon expiry of such cure period in case of (ii), and six (6) months after notice to FibroGen in case of (iii).


More Definitions of Technical Product Failure

Technical Product Failure means as a [*], which is not attributed to Astellas’ failure to fulfill its obligations hereunder.
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Technical Product Failure means (i) a [ * ] (as hereinafter defined) which is not attributed to Astellas’ failure to fulfill its obligations hereunder (including, without limitation, such a [ * ] based upon results from completed or terminated toxicology or other preclinical studies provided, that for FG-2216 only, results generated pursuant to such a toxicology or other preclinical study performed by or on behalf of Astellas and approved by either FibroGen or the JDRC or performed by or on behalf of FibroGen may be considered for purposes of this subsection (i), and, provided, further that the seven preclinical studies identified on Exhibit C which have already been approved by the JDC shall be deemed approved by FibroGen — obtained after the Effective Date, in which case a party may require (upon written request) that the JSC retain an independent expert panel, such experts to be chosen in equal numbers by each of FibroGen and Astellas, to obtain an opinion as to whether such results constitute such a [ * ], which opinion the JSC shall consider in good faith (and which procedure shall be subject to the timing provisions set forth in the third paragraph of the “Term and Termination” section below), (ii) a statistically significant ([ * ]) increase over placebo in [ * ], or a statistically significant ([ * ]) increase over placebo and marketed recombinant erythropoietin products in [ * ] Products, (iii) a serious problem in the safety (including, without limitation, such serious problems based upon toxicology or other preclinical results obtained after the Effective Date) of all of the then existing Products not related to manufacture (provided such manufacturing problem may be remedied) occurs which prevents all of the then existing Products from obtaining required clearance for entering or continuing human clinical trials for all of the Core Indications (or which otherwise results in all Products being prevented from entering human clinical trials) for a period of [ * ] after such event occurs in the event no Product has yet received Marketing Approval, (iv) after a Product has obtained Marketing Approval, the Marketing Approvals in [ * ] for all Products on the market in such countries are revoked or suspended for a period of at least [ * ], or (v) receipt of non-approvable letters from appropriate regulatory authorities for not less than [ * ] indications each. For the avoidance of doubt, results from clinical studies of [ * ] shall not by themselves form the basis of Technical...
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Technical Product Failure means (i) a [ * ] (as hereinafter defined) which is not attributed to Astellas’ failure to fulfill its obligations hereunder (including, without limitation, such a [ * ] based upon results from completed or terminated toxicology or other preclinical studies provided, that for FG-2216 only, results generated pursuant to such a toxicology or other preclinical study performed by or on behalf of Astellas and approved by either FibroGen or the JDRC or performed by or on behalf of FibroGen may be considered for purposes of this subsection (i), and, provided, further that the seven preclinical studies identified on Exhibit C which have already been approved by the JDC shall be deemed approved by FibroGen — obtained after the Effective Date, in which case a party may require (upon written request) that the JSC retain an independent expert panel, such experts to be chosen in equal numbers by each of FibroGen and Astellas, to obtain an opinion as to whether such results constitute such a [ * ], which opinion the JSC shall consider in good faith (and which procedure shall be subject to the timing provisions set forth in the third paragraph of the “Term and Termination” section below), (ii) a statistically significant ([ * ]) increase over placebo in [ * ], or a statistically significant ([ * ]) increase over placebo and marketed recombinant erythropoietin products in [ * ] Products, (iii) a serious problem in the safety (including, without limitation, such serious problems based upon toxicology or other preclinical results obtained after the Effective Date) of all of the then existing Products not related to manufacture (provided such manufacturing problem may be remedied) occurs which prevents all of the then existing Products from obtaining required clearance for entering or continuing human clinical trials for all of the Core Indications (or which otherwise results in all Products being prevented from entering human clinical trials) for a period of [ * ] after such event occurs in the event no Product has yet received Marketing Approval, (iv) after a Product has obtained Marketing Approval, the Marketing Approvals in [ * ] for all Products on the market in such countries are revoked or suspended for a period of at least [ * ], or (v) receipt of non-approvable letters from appropriate regulatory authorities for not less than [ * ] indications each. For the avoidance of doubt, results from clinical studies of [ * ] shall not by themselves form the basis of Technical...
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Technical Product Failure means (a) a [ * ] of a Collaboration Compound or Product under Development or Commercialization under this Agreement, as determined (including following a review of the Carcinogenicity Studies) (i) by a consensus decision by the JSC or (ii), following referral of the matter to the Executive Officers pursuant to Section 2.6(c), by a consensus decision by the Executive Officers, or (iii), in the event that a consensus decision by the Executive Officers has not been attained within twenty (20) Business Days after the JSC’s
Sample 1
Technical Product Failure means (a) a [*] of a Collaboration Compound or Product under Development or Commercialization under this Agreement, as determined (i) by a consensus decision by the China Committee or the JSC (if the China Committee cannot reach consensus) or (ii) following referral of the matter to the Executive Officers pursuant to Section 2.2(e) and Section 2.6(c) of the U.S. and RoW Agreement, by a consensus decision by the Executive Officers, or (iii) in the event that a consensus decision by the Executive Officers has not been attained within twenty (20) Business Days after the JSC’s submission of the matter to them,
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Related to Technical Product Failure

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

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

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • API means the American Petroleum Institute.

  • Defective Product has the meaning set forth in Section 5.2.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Warranty Period /„Maintenance Period‟ shall mean the period during which the Contractor shall remain liable for repair or replacement of any defective part of the Works performed under the Contract.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;