Early Stage Development definition

Early Stage Development means all post-IND Development up to and including conclusion of Phase II Studies.
Early Stage Development means that part of the Early Stage Development Program comprising the research, preclinical and clinical activities with respect to approved Collaboration Products in North America through the completion of Phase I clinical trials.
Early 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’s Selection through the completion of [***] and ending at the start of [***].

Examples of Early Stage Development in a sentence

  • RPRP and Introgen shall each have access to and the right to use for any purpose, including incorporation in any regulatory filing, any preclinical and/or clinical data with respect to the Collaboration Product developed by Introgen or RPRP in the course of the Early Stage Development Program or otherwise (including in the Co-Exclusive Territory or the RPRP Territory).

  • Beginning in 1995, by August 1 of each year during the Early Stage Development Program, Introgen shall submit to the Development Committee a proposed Program Plan and Budget for the Early Stage Development Program for the following calendar year.

  • With respect to matters relating to Early Stage Development, Introgen's lead representative shall chair meetings of the Development Committee, and with respect to matters relating to Later Stage Clinical Development, RPRP's lead representative shall chair such meetings.

  • Unless otherwise agreed by the parties, Introgen shall not be obligated to incur nor shall RPRP be obligated to pay Early Stage Development Program Costs in connection with the Early Stage Development Program beyond amounts provided for in the approved Program Plan and Budget.

  • Inventorship of inventions and other intellectual property rights conceived and/or reduced to practice in connection with the Early Stage Development Program shall be determined in accordance with the patent and other intellectual property laws of the United States.

  • The activities conducted in connection with the Early Stage Development Program will be overseen and administered by the Development Committee, pursuant to Article 3 below.

  • Introgen shall be responsible for preparing reasonably detailed plans and budgets on an annual basis for the "Program Plan and Budget" through which the Early Stage Development Program will be carried out.

  • The Early Stage Development Program shall include all of the approved Program Plans and Budgets in effect from time to time.

  • From time to time, upon agreement of RPRP and Introgen, new projects may be added to the Early Stage Development Program to be developed as Collaboration Products.

  • Concurrently with the submission and establishment of Product Plans and Budgets for the Early Stage Development to be conducted under the Early Stage Development Program in accordance with Section 3.4 above, RPRP shall submit to the Development Committee an outline of the Product Plan and Budget for Later Stage Clinical Development for each Collaboration Product in North America.


More Definitions of Early Stage Development

Early 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 achieves Drug Evaluation Acceptance through the completion of Phase IIa Clinical trials and ending at the start of Phase IIb Clinical Trials.
Early Stage Development means, with respect to any indication for a Product, all post-IND filing Development commencing on the first filing of an IND for such indication and continuing up to and including the completion of Phase II Studies or commencement of Pivotal Studies, whichever is earlier for such indication.
Early Stage Development means (i) the activities to be conducted regarding the planning and execution, of pre-clinical and clinical development of a particular Product, beginning upon identification of a Compound as Development Candidate, and ending with the completion of

Related to Early Stage Development

  • 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;

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria:

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

  • 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.

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

  • 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.

  • 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.

  • 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;

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

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

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

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

  • Major development means an individual “development,” as well as multiple developments that individually or collectively result in:

  • Development Program means the implementation of the development plan.

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

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • 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.

  • Development Tools means the development kits, programming tools, emulators and other materials that may be used in the development of Games under this Agreement.

  • 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.

  • 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.

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • Development Tool Kit means a DS Offering specifically designed for application or content development. A Development Tool Kit is either identified (i) with “CAA” or “ENOVIA Studio” in the DS Offering name, or (ii) in the Transaction Document and/or the Product Portfolio. Extended Enterprise User means an employee of Customer’s affiliate(s), supplier(s) and/or customer(s) authorized to use Customer’s DS Offering for the sole and exclusive purpose of enabling the Extended Enterprise User(s) to conduct business with Customer. The use of the DS Offering by any such Extended Enterprise User(s) 1) shall be solely limited to use (a) as configured and deployed by Customer and (b) in connection with the Extended Enterprise User’s performance of services for and on behalf of Customer, and 2) shall exclude any use by Extended Enterprise User (a) for its own account or a third party’s account, or (b) for the purpose of modifying, otherwise using, maintaining or hosting the DS Offering. Extended Enterprise Users are authorized if so specified in the Product Portfolio.

  • 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.

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

  • 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.