Other Global Development Plan definition

Other Global Development Plan means a plan setting forth the Development activities that are (a) not included in the Current Global Development Plan, (b) not [***], and (c) to be undertaken by or on behalf of Akebia and its Affiliates, licensees (including Licensee, if applicable), and sublicensees in Developing the Licensed Compound and the Licensed Products and obtaining or maintaining Regulatory Approval from [***] for New Indications or New Formulations, as set forth in Section 4.3 (Additional Development), together with the budget and timelines for such activities including the proposed clinical trials and regulatory plans, as well as outlining the key elements involved in obtaining and maintaining Regulatory Approval of the Licensed Products from [***] (other than as contemplated in the Current Global Development Plan or [***] or any [***] Plan).
Sample 1
Other Global Development Plan means a plan setting forth the activities in connection with any Other Global Development to be undertaken by or on behalf of Akebia and its Affiliates, licensees (including Licensee, if applicable), and sublicensees, together with the budget and timelines for such activities including the proposed clinical trials, regulatory plans, and manufacturing plans as well as outlining the key elements involved in obtaining and maintaining Regulatory Approval of the Licensed Products from the FDA and the EMA (other than as contemplated in the Current Global Development Plan or any Territory-Specific Development Plan).
Sample 1

Examples of Other Global Development Plan in a sentence

  • Akebia and Licensee will perform, and each will ensure that their Affiliates and licensees and permitted sublicensees (as applicable), and subcontractors perform, all Development activities under the Current Global Development Plan, Other Global Development Plan, Territory-Specific Development Plan, or any [***] Plan, as the case may be, in a good scientific manner, in accordance with GLP, GMP, and GCP, as applicable, and in compliance with Applicable Law.

Related to Other Global Development Plan

  • Global Development Plan has the meaning set forth in Section 3.1.

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

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

  • 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;

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

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

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • 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;

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • 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.

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • 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.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • 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, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • Economic development incentive means a financial incentive,

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

  • Economic development means all powers expressly granted and reasonably inferred pursuant to SDCL § 9-54.

  • Michigan economic development corporation means the public body corporate created under section 28 of article VII of the state constitution of 1963 and the urban cooperation act of 1967, 1967 (Ex Sess) PA 7, MCL 124.501 to 124.512, by a contractual interlocal agreement effective April 5, 1999, as amended, between local participating economic development corporations formed under the economic development corporations act, 1974 PA 338, MCL 125.1601 to 125.1636, and the Michigan strategic fund. If the Michigan economic development corporation is unable for any reason to perform its duties under this act, those duties may be exercised by the Michigan strategic fund.

  • Development Program means the implementation of the development plan.

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

  • Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.

  • Planned unit development means a subdivision characterized by a unified site design, clustered residential units and/or commercial units, and areas of common open space.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.