Late Stage Development definition

Late Stage Development means Development following completion of Phase II Studies up to and including filing of a Drug Approval Application for an Antibody Product in any jurisdiction and including any supplementary Development necessary or required by a Regulatory Authority (a) in order to obtain a Regulatory Approval; or (b) as required as a condition or maintenance, as the case may be, of a Regulatory Approval; in each case necessary for the commercial sale and/or use of an Antibody Product in that jurisdiction.
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Late Stage Development means, with respect to a product, that first dosing under Phase 2 Studies has been initiated.
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Late Stage Development means the development activities that are conducted in connection with a Collaboration Compound during the period of time beginning on the date a Collaboration Compound enters [***] up until Regulatory Approval.
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Examples of Late Stage Development in a sentence

  • Each Party shall provide the Joint Development Committee with a good faith preliminary estimate of its pre-launch Commercialisation Costs of an Antibody Product on or about the date Amgen provides written notice to Celltech that it intends to proceed with Late Stage Development activities with respect to such Antibody Product.

  • Reasonably in advance of the Initiation of Late Stage Development Activities for each Collaboration Program, the JPT will prepare a Transition Plan to be approved by the Parties for the transfer of the Development Lead with respect to such Optioned Product from Denali to Takeda.

  • The costs of manufacture, including scale-up and validation of Antibody Raw Material and Antibody Product in Finished Form, shall be deemed Research and Development Costs of Late Stage Development to the extent only that Antibody Raw Material and Antibody Product in Finished Form so produced is not used for Commercialisation and otherwise shall be a Cost of Goods.

  • The Development Lead shall be responsible for preparing clinical trial designs and protocols, sponsoring Clinical Studies, engaging Third Party Providers, and shall be primarily responsible for the conduct of any such Early Stage Development Activities or Late Stage Development Activities, as the case may be, consistent with the then-current Development Plan for such Collaboration Program.

  • Notwithstanding the initiation of Late Stage Development Activities for a particular Optioned Product within a Collaboration Program for an Indication, unless otherwise agreed, Denali will continue to be Development Lead for [***].

  • Verve will have the right but not the obligation, at its sole cost, to defend against any other declaratory judgment action or other action challenging any Acuitas Patent that, on the date of first notice of such action, are not necessary or useful for the research, development, manufacturing and commercialization of any lipid nanoparticle comprising product that is licensed or optioned by Acuitas to a Third-Party or is under Late Stage Development by Acuitas.

  • Within [***] of Kiniksa’s receipt of a notice from Regeneron pursuant to this Section 5.7 (Regeneron Late Stage Development in the Regeneron Retained EEO Field), the Parties shall negotiate in good faith and enter into an amendment to this Agreement to allow Regeneron to independently Develop and Commercialize the Product in the Regeneron Retained EEO Field in the Territory and, at the same time, allow Kiniksa to independently Develop and Commercialize the Product in the Kiniksa Field in the Territory.

  • Laureà Miró, 408-410Sant Feliu de Llobregat, 08980 Barcelona, SpainEsther Garcia Gil, MD; Head of Late Stage Development RespiratoryGemma Jiménez, EU QPPV, Head of Corporate Drug SafetyNote: Additional research teams may participate, depending on the actual use of aclidinium bromide in countries with databases.

  • A Study Monitor from Covance Late Stage Development Services will be responsible for monitoring this clinical trial.

  • GreenLight will have the right but not the obligation, at its sole cost, to defend against any other declaratory judgment action or other action challenging any Acuitas Patent that, on the date of first notice of such action, are not necessary or useful for the research, development, manufacturing and commercialization of any lipid nanoparticle comprising product that is licensed or optioned by Acuitas to a Third-Party or is under Late Stage Development by Acuitas.


More Definitions of Late Stage Development

Late Stage Development means Development after the Initiation of a Phase 3 Study.
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Late Stage Development means the development activities that are conducted in connection with a Development Compound during the period of time beginning on the date a Development Compound enters Phase IIb Clinical Trials up to and including Regulatory Approval.
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Late Stage Development means, with respect to any indication for a Product, all Development following the completion of Phase II Studies or commencement of Pivotal Studies, whichever is earlier for such indication, up to and including filing of the first Drug Approval Application for such indication in any jurisdiction and including any supplementary Development necessary or required by a Regulatory Authority (a) in order to obtain the first Regulatory Approval for such indication; or (b) to satisfy any conditions of the first Regulatory Approval in that jurisdiction.
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Late Stage Development means activities to be conducted regarding (i) Phase III Clinical Studies, beginning with the decision to commence Phase III Clinical Studies for such Product for a particular Indication or Indications, including clinical trial designs for Phase III Clinical Studies and the determination of which Products will be developed for which Indications; (ii) any Post-approval Clinical Trials for a particular Product; and (iii) any interactions with any Regulatory Authority regarding such activities.
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Late Stage Development means with respect to a product that [*****] Studies have been initiated.
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Related to Late Stage Development

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

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • 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.

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

  • the Development means the residential development for –

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • 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;

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Commencement of Development means the date on which any material operation (as defined in Section 56(4) of the Act) forming part of the Development begins to be carried out other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations, investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying of services, erection of any temporary means of enclosure, the temporary display of site notices or advertisements and “Commence Development” shall be construed accordingly.

  • 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.

  • 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.

  • New development means development resulting from the conversion of previously undeveloped land or agricultural land uses.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • 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.

  • Commercial cannabis activity means the production, cultivation,

  • Development Program means the implementation of the development plan.

  • Mixed use development means a Building used, designed or intended for Residential and Non-Residential uses, where:

  • Substantial development means any development of which the total cost or fair market value exceeds two thousand five hundred dollars, or any development which materially interferes with the normal public use of the water or shorelines of the state; except that the following shall not be considered substantial developments for the purpose of this chapter:

  • Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.

  • sustainable development means development that meets the needs of the present generation without compromising the ability of future generations to meet their own needs;