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

  • The signature of the investigator (including electronic signature, as appropriate) will designate the investigator’s review of the eCRFs. All source documents, records, and reports will be retained by the Covance Late Stage Development Services in accordance with 21 CFR 312.62(c).

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

  • 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.

  • For the avoidance of doubt, with respect to any such intention set forth in such Late Stage Development Plan, other than as set forth in a revised Late Stage Development Plan provided pursuant to Article 3.4(b) below, Amgen shall not be obliged to inform Celltech of any change to Amgen’s intention after providing such Late Stage Development Plan pursuant to this Article 3.4(a).

  • However, Celltech’s opt out right shall apply to any other Antibody Product that Amgen proposes to advance or advances to Late Stage Development, and Articles 3.4(a) and (b) shall apply mutatis mutandis to all such Antibody Products.

  • 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.

  • Notwithstanding any other term of this Agreement, [*] shall not, except with the written consent of [*], have an Antibody Product in Late Stage Development in more than one [*] unless (i) Regulatory Approval for the Commercialisation of an Antibody Product has been obtained in any of the [*] or (ii) such additional [*] was included in the first [*] for such Antibody Product presented to [*] pursuant to Article [*].

  • All pages except for the title page and the signature page must be numbered.

  • 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.

  • Marchenko, PhDVice President, Center for Statistics in Drug Development InnovationQuintilesKeaven Anderson, PhDExecutive Director, Statistics: Late Stage Development MerckPeiling Yang, PhDTeam Lead, Division of Biometrics I Office of BiostatisitcsOffice of Translational Sciences CDER, FDAThomas Laughren, MDDirector, Division of Psychiatry Products Office of Drug Evaluation ICDER, FDA 3:00-3:30 pm AFTERNOON BREAK 3:30-5:30 pm JOINT SESSION 4 Role of DMC in Adaptive DesignsSeSSion ChairperSonLisa M.


More Definitions of Late Stage Development

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 Development after the Initiation of a Phase 3 Study.
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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 with respect to a product that [*****] Studies have been initiated.
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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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Related to Late Stage Development

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Development Works means the external development works and internal development works on immovable property;

  • 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.

  • 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 is begun other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying out of services, erection of any 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:

  • Digital audio-visual work means a series of related images which, when shown in succession, imparts an impression of motion, together with accompanying sounds, if any.

  • The Works/Project means the works to be executed or done under this contract.