Development Tasks definition

Development Tasks has the meaning specified in Section 4.1.
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Development Tasks means, with respect to each Designated Product: 1. those tasks or milestones, together with estimated completion dates or durations therefor, as shall be designated from time to time by Committee Action as being, within industry norms and standards, sufficient evidence of a potentially useful and marketable product that the next steps in the development of such product would be Certification Tasks, or (where no Certification Tasks have then been designated by Committee Action) large-scale clinical trials to determine the safety and efficacy of such Designated Product; and 2. the designation by Committee Action of an initial set of Certification Tasks and an initial Certification Budget for such Designated Product. In most instances, the Development Tasks will include (without limitation) formulation development, in vitro dissolution studies and/or animal studies and bioavailability studies, as well as small-scale clinical trials conducted under an Investigational New Drug Application ("IND") filed with the FDA, of the sort called "Phase I Clinical Trials" and "Phase II Clinical Trials" in order to demonstrate that, within the scope of such studies, the Designated Product is shown, when administered BID, to be a stable formulation having substantially equigesic effect in blood level studies to the targeted dosage strength of the relevant immediate release Oxymorphone product. In most cases, the large-scale trials to follow during the Certification Period would be of the sort called "Phase III Clinical Trials" in the FDA context. However, the applicable Development Tasks may be defined and altered in specific cases by Committee Action, whether or not in conformity with the above described usual case as now anticipated.
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Development Tasks shall have the meaning set forth for such term in Section 3.4.
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Examples of Development Tasks in a sentence

  • Using the illustrative milestone template provided below as a guide, please provide a set of milestones that provide a clear path to completion of the proposed Research & Development Tasks, with specific proposed “Go-No Go” milestones at the end of each year of the proposed project Milestones should be objective and, where possible, quantitative.

  • Clearly describe how the proposed approach differs from others under investigation in the field.b. Approach Provide detailed experimental plans for the completion of the tasks and goals specified in the Research & Development Tasks section.

  • Seller shall provide Notice to Purchaser within five (5) Business Days when all of the Development Tasks have been satisfied or achieved by Seller (the “Development Completion Notice”), and Seller is ready to proceed with installation of the System.

  • Research & Development Tasks (1 page)Describe succinctly the purpose of the overall research and development program, the underlying hypothesis(es)/technical concept(s) guiding the approach, and a list of the specific tasks you will undertake and accomplish to achieve your purpose.

  • If Changes will result in an increase in the cost of the Development Tasks or Deliverables, the parties shall agree in writing upon an estimate of additional time and material costs for the accomplishment of any Changes.

  • If any of the Development Tasks have not been satisfied in their entirety (or otherwise waived in writing by Purchaser, in its sole discretion) within one hundred twenty five (125) Business Days (and such 125 Business Day period shall not include time for reviews or modifications pursuant to Section 4.1 and shall be extended on a day-for- day basis pursuant to Section 4.1), then either Party may terminate this Agreement upon thirty (30) Days Notice of such termination to the other Party.

  • Because the Development Tasks reflects the contents of the Implementation Specifications, the Business Rules are linked to the Implementation Specifications.

  • The source of the Implementation Specifications is the Development Tasks in the FCR.

  • Seller shall provide Notice to Purchaser within five (5) Business Days when all of the Development Tasks have been satisfied or achieved by Seller, and Seller is ready to proceed with installation of the System.

  • If any of the Development Tasks have not been satisfied in their entirety (or otherwise waived in writing by Purchaser, in its sole discretion) on or before [•], then either Party may terminate this Agreement upon [thirty (30)] Days Notice of such termination to the other Party.


More Definitions of Development Tasks

Development Tasks means the Development Tasks under the Original Agreement.
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Development Tasks means those activities and responsibilities of ----------------- each party that will be part of the Development Project, as more fully described from time to time in the Development Plan and Budget. The Development Tasks shall include with respect to a particular Licensed Product, as more fully described in the Development Plan and Budget: (a) preparation for [ * ]; (b) preclinical [ * ] performed in preparation for the [ * ] surveillance [ * ] all other applicable regulatory obligations [ * ] animal subjects; (c) [ * ] of, and obtaining [ * ] including [ * ]; (d) [ * ] for activities under the [ * ]; (e) [ * ]; (f) preparation and [ * ]; (g) [ * ] as to specific indications, as required or agreed [ * ]; (h) [ * ] by one party hereunder to the other party [ * ] but not in any event less stringent than [ * ] and to the appropriate [ * ] with respect to [ * ] arising during the [ * ] for such [ * ] and associated with such [ * ] or any [ * ]; and (i) such other activities, regardless of [ * ] that are [ * ] as determined by [ * ] in order to obtain [ * ]. Unless the parties agree otherwise, [ * ] shall have the primary responsibility for the [ * ] described in [ * ] provided, however, that the parties hereto shall [ * ] covered by any of the inventions or technologies [ * ] and shall give [ * ] to such [ * ] provided it is able and willing [ * ] under terms and conditions [ * ] to the parties hereto than the terms and conditions under which [ * ] is able and willing to [ * ].
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Development Tasks means those activities and responsibilities of ----------------- each party that will be part of the Development Project, as more fully described from time to time in the Development Plan and Budget. The Development Tasks shall include with respect to a particular Licensed Product, as more fully described in the Development Plan and Budget: [*] [*] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission Unless the parties agree otherwise, [*]
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Development Tasks has the meaning specified in Section 4.1. “Dispute” has the meaning specified in Section 14.5(a).
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Development Tasks means those steps, phases, activities, and ----------------- responsibilities of each party and its Contractors that will be part of each Development Project, as more fully described in the applicable Project Plan and Budget. Subject to Section 4.3, the Development Tasks will include, but not be limited to the following: (i) The "Biogen Development Tasks," which are defined as follows: ------------------------- (A) preclinical biology and animal studies; (B) final formulation development, design and optimization; (C) human clinical trials; (D) preparation and submission of all regulatory filings other than BMFs [*]; and (E) activities related to the Initial Ad Interferon-beta Project Plan and Budget. (ii) The "Targeted Development Tasks," which are defined as follows: --------------------------- (A) vector design and optimization; (B) manufacturing process development, optimization, scale-up and validation; (C) assay development, qualification, and validation; (D) manufacture of Research Vectors and Clinical Vectors; and [*] Confidential Treatment Requested (E) creation and management of BMFs, and filing of BMFs for regulatory purposes.
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Related to Development Tasks

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

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

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Research Program has the meaning set forth in Section 3.1.

  • 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.

  • Development Project means a project for the development of land within a project area.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Research Budget has the meaning set forth in Section 2.2.

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Development Area means that area to which a development plan is applicable.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalised Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Commercialization Plan has the meaning set forth in Section 6.2.

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