Active Early Development definition

Active Early Development of a Product means that at any given time TMC is diligently engaging in one or more of the following development activities for such Product in the Field: (a) formulation development; (b) preclinical studies to evaluate delivery or the feasibility of a prototype Product; (c) preclinical studies to evaluate pharmacokinetics, pharmacodynamics, and/or safety of a prototype Product; and (d) analytical development.
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Active Early Development means that Barrier is diligently engaging in one or more of the following development activities for a Product it has selected to develop: (i) lead optimization; (ii) pre-clinical development (pharmacology, toxicology, drug safety and pharmacokinetics studies); (iii) chemical, pharmaceutical and analytical development; or (iv) early clinical development.
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Active Early Development of a Product means that at any given time TMC is diligently engaging in one or more of the following development activities for such Product in the Field: (a) formulation development; (b) preclinical studies to evaluate delivery or the feasibility of a prototype Product;
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Examples of Active Early Development in a sentence

  • In the event that Barrier is not conducting Active Early Development on a Ketanserin Product by [**] JPPLP shall be entitled, but not obligated, to terminate (i) Barrier's license to the Ketanserin Patent Rights under Section 2.3 and (ii) Barrier's license to JPPLP Know-How relating to the Ketanserin Product under Section 3.1.

  • In the event that (i) Barrier has not obtained Regulatory Approval or is not conducting Active Early Development or Active Clinical Development on each such Product as contemplated in Sections 8.2 to 8.6 above, and (ii) JPPLP desires to exercise its termination rights pursuant to Sections 8.2, 8.3, 8.4, 8.5 or 8.6 above, then, no later than two months following the receipt of such Section 8.7 Report, JPPLP shall send to Barrier written notice of its election to do so.

  • In the event that Barrier is not conducting Active Early Development on a `096 Product by [**], JPPLP shall be entitled, but not obligated, to terminate (i) Barrier's license to the `096 Patent Rights under Section 2.2 and (ii) Barrier's license to JPPLP Know-How relating to the `096 Product under Section 3.1.

  • In the event that Barrier is not conducting Active Early Development on an Oxatomide Product by [**] JPPLP shall be entitled, but not obligated, to terminate Barrier's license to Oxatomide Know-How relating to the Oxatomide Product under Section 3.2.

  • In the event that JPPLP does not so exercise its right to terminate, then JPPLP shall be deemed to have waived its right to terminate such Patent Right, as applicable, and the related JPPLP Know-How or Oxatomide Know-How; provided, however, that in the event that such failure to obtain Regulatory Approval or conduct Active Early Development or Active Clinical Development is continuing as of [**] then JPPLP's termination rights contained in Sections 8.2 to 8.6, as applicable, shall be reinstated.

  • Barrier shall send to JPPLP a new Section 8.7 Report during the month of [**] and if JPPLP desires to exercise such rights, then JPPLP shall send to Barrier written notice of its election to do no later than two months following the receipt of such new Section 8.7 Report, with a similar waiver and reinstatement occurring on an annual basis until Barrier commences Active Early Development, Active Clinical Development or obtains Regulatory Approval.

  • In the event that Barrier is not conducting Active Early Development on one JPPLP Product [**] by [**] JPPLP shall be entitled, but not obligated, to terminate (i) Barrier's license to the JPPLP Patent Rights under Section 2.1 and (ii) Barrier's license to JPPLP Know-How relating to JPPLP Products under Section 3.1.

  • Barrier shall send to JPPLP during the month of [**], [**] and/or [**] a report on the status of its development for each Product indicating whether Barrier has obtained Regulatory Approval or is in Active Early Development or Active Clinical Development for each such Product (the "Section 8.7 Report").

Related to Active Early Development

  • 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;

  • 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:

  • Inclusionary development means a development containing both affordable units and market rate units. This term includes, but is not necessarily limited to: new construction, the conversion of a non-residential structure to residential and the creation of new affordable units through the reconstruction of a vacant residential structure.

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

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

  • Inactive business operations means the mere continued holding or renewal of rights to property previously operated for the purpose of generating revenues but not presently deployed for such purpose.

  • Active business operations means all business operations that are not inactive business operations.

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

  • Community Developmental Disability Program (CDDP means an entity that is responsible for planning and delivery of services for individuals with developmental disabilities in a specific geographic service area of the state operated by or under a contract with the Division or a local mental health authority.

  • 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;

  • High-technology activity means that term as defined in section 3 of the Michigan economic growth authority act, 1995 PA 24, MCL 207.803.

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

  • 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;

  • Cluster development means a contiguous cluster or

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Total Development Cost means the total of all costs incurred in the completion of a Development, all of which shall be subject to the review and approval by the Credit Underwriter and the Corporation pursuant to this rule chapter, and as further described in Rule 67-48.0075, F.A.C.

  • Temporary clean coal technology demonstration project means a clean coal technology demonstration project that is operated for a period of five years or less and that complies with the SIP and other requirements necessary to attain and maintain the national ambient air quality standards during the project and after the project is terminated.

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

  • Specified anatomical areas means and includes:

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

  • Development Location Point means a single point selected by the Applicant on the proposed Development site that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development. For a Development which consists of Scattered Sites, this means a single point on the site with the most units that is located within 100 feet of a residential building existing or to be constructed as part of the proposed Development.

  • Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.

  • land development area means an erf or the land which is delineated in an application submitted in terms of this By-law or any other legislation governing the change in land use and “land area” has a similar meaning;

  • Exploration Period means the period mentioned in Article 3 during which Exploration Operations may be carried out by the Contractor as provided in Article 3 hereof.

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

  • Best available control technology (BACT means an emissions limitation (including a visible emission standard) based on the maximum degree of reduction for each pollutant subject to regulation under CAA which would be emitted from any proposed major stationary source or major modification which the Department, on a case-by-case basis, takes into account energy, environmental, and economic impacts and other costs, determines is achievable for such source or modification through application of production processes or available methods, systems, and techniques, including fuel cleaning or treatment or innovative fuel combustion techniques for control of such pollutant. In no event shall application of best available control technology result in emissions of any pollutant which would exceed the emissions allowed by any applicable standard under 7 DE Admin. Code 1120 and 1121. If the Department determines that technological or economic limitations on the application of measurement methodology to a particular emissions unit would make the imposition of an emissions standard infeasible, a design, equipment, work practice, operational standard, or combination thereof, may be prescribed instead to satisfy the requirement for the application of best available control technology. Such standard shall, to the degree possible, set forth the emissions reduction achievable by implementation of such design, equipment, work practice or operation, and shall provide for compliance by means which achieve equivalent results.