ROW Development definition

ROW Development means the Development of the Products specifically required only in a certain country or countries of the Royalty Territory to support Regulatory Approval of the Product for the Initial Indications and/or the Joint Additional Indications, if any, in such country or countries of the Royalty Territory, irrespective of the country wherein a study thereof is conducted. For the purpose of this definition, Manufacturing Development shall be excluded from the ROW Development.
ROW Development has the meaning set forth in Section 3.1.2.

Examples of ROW Development in a sentence

  • Promptly after the CCPS Agreement Effective Date, Celgene will prepare an initial ROW Development Plan and will provide it to the JGC for purposes of discussion and the goal of coordinating and harmonizing the U.S. Development Plan and the ROW Development Plan.

  • As of and after the CCPS Agreement Effective Date, subject to the terms and conditions of this CCPS Agreement, the Parties will assume through the JGC joint responsibility for Development of Elected Candidate and Licensed Product for U.S. Administration, under the U.S. Development & Commercialization Program, and Celgene will assume responsibility for Development of Elected Candidate and Licensed Product for ROW Administration, under the ROW Development & Commercialization Program.

  • Such reports shall set forth in summary form the results of GSK's Development activities with respect to Collaboration Products for Commercialization in the ROW performed during such semi-annual period and any updates to such ROW Development Plan.

  • API Compound requirements for Development activities shall be set forth in the relevant U.S. Development Plans and ROW Development Plans and shall be periodically updated by the Joint Supply Committee in coordination with the Joint Development Committee and the Joint Steering Committee.

  • For avoidance of doubt, the JGC will have no right to supervise or direct the Development and Commercialization of Elected Candidate or Licensed Product for ROW Administration, and Celgene will have sole decision making authority with respect to such Development and Commercialization, including with respect to the ROW Development & Commercialization Program.

  • In the event that GSK fails -------------------------------- to achieve any of the timeline events set forth in this Section 16.8 or in the U.S. Development Plan or ROW Development Plan, as applicable, due to a delay by Adolor to supply API Compound necessary to achieve such timeline events, then the timeline shall be extended by a period of time equal to the length of such delay.

  • Promptly after the CCPS Agreement Effective Date, Celgene will prepare an initial U.S. Development Plan, and the JGC will review and approve such initial U.S. Development Plan, with the goal of coordinating and harmonizing the U.S. Development Plan with the ROW Development Plan.

  • As early as necessary in each year beginning with the first full ------- Calendar Year after the Effective Date, GSK shall prepare a Development plan for each Collaboration Product in the ROW (each, a "ROW Development Plan") so that -------------------- it can submit such ROW Development Plans to the Joint Steering Committee no later than September 30 of such year for review.

  • Formulated Collaboration Product requirements for Development activities shall be set forth in the relevant U.S. Development Plans and ROW Development Plans and shall be periodically updated by the Joint Supply Committee in coordination with the Joint Development Committee and the Joint Steering Committee.

  • Thereafter, Celgene will update the ROW Development Plan each year and submit it to the JGC for purposes of discussion and the goal of coordinating and harmonizing the U.S. Development Plan and ROW Development Plan.

Related to ROW Development

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

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

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

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

  • 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:

  • the Development means the residential development for –

  • Residential Development means lands, buildings or structures developed or to be developed for residential use;

  • 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.

  • 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.

  • sustainable development means development which meets the needs of the present without compromising the ability of future generations to meet their own needs.

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

  • Development means any man-made change to improved or unimproved real estate, including, but not limited to, buildings or other structures, mining, dredging, filling, grading, paving, excavation or drilling operations, or storage of equipment or materials.

  • Employee Developments means any idea, discovery, invention, design, method, technique, improvement, enhancement, development, computer program, machine, algorithm or other work or authorship that (i) relates to the business or operations of the Company or any of its subsidiaries or affiliates, or (ii) results from or is suggested by any undertaking assigned to the Employee or work performed by the Employee for or on behalf of the Company or any of its subsidiaries or affiliates, whether created alone or with others, during or after working hours. All Confidential Information and all Employee Developments shall remain the sole property of the Company or any of its subsidiaries or affiliates. The Employee shall acquire no proprietary interest in any Confidential Information or Employee Developments developed or acquired during the Term. To the extent the Employee may, by operation of law or otherwise, acquire any right, title or interest in or to any Confidential Information or Employee Development, the Employee hereby assigns to the Company all such proprietary rights. The Employee shall, both during and after the Term, upon the Company’s request, promptly execute and deliver to the Company all such assignments, certificates and instruments, and shall promptly perform such other acts, as the Company may from time to time in its discretion deem necessary or desirable to evidence, establish, maintain, perfect, enforce or defend the Company’s rights in Confidential Information and Employee Developments.

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