US Development definition

US Development has the meaning set forth in the preamble.
US Development means, with respect to the Profit-Share Product, Development activities intended to support the filing of an MAA (including any supplement or amendment thereto) for the Profit-Share Product in the U.S.
US Development. Costs shall mean (i) one hundred (100%) of Development Costs (as defined in Section 1.9) through the end of Phase II plus (ii) fifty percent (50%) of Development Costs in the United States and Europe, beginning in Phase III through filing of NDA/BLA. ________________________________________________________________________________ ** Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission.

Examples of US Development in a sentence

  • About USD Partners LPUSD Partners LP is a fee-based, growth-oriented master limited partnership formed in 2014 by US Development Group, LLC (“USD”) to acquire, develop and operate midstream infrastructure and complementary logistics solutions for crude oil, biofuels and other energy-related products.

  • In addition, either Party may request at any time that the JGC consider and approve other updates to the U.S. Development Plan.

  • 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.

  • Subject to the terms and conditions of this CCPS Agreement, (i) the Parties will assume through the JGC joint responsibility for Commercialization of Licensed Product for U.S. Administration under the U.S. Development & Commercialization Program, and (ii) Celgene will assume sole responsibility for Commercialization of Licensed Product for ROW Administration (including all costs and expenses arising therefrom).

  • Each Party, directly or through one or more of its Affiliates, Sublicensees or permitted subcontractors, will use Commercially Reasonable Efforts to perform the obligations assigned to such Party by the JGC under the U.S. Development & Commercialization Program.

  • 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.

  • After any such Regulatory Approval for such Licensed Product in the United States, any Manufacturing activities for Commercialization of Licensed Product for U.S. Administration will be included in and will be part of the U.S. Commercialization Plan and the U.S. Development and Commercialization Program.

  • In connection with the preparation and implementation of the U.S. Development Plan, Adolor and GSK will make available to the Joint Development Committee any information then in their possession pertaining to the Collaboration Products useful for such Development activities.

  • Each Party will ---------------------------------------- inform the Joint Development Committee of ongoing implementation of the U.S. Development Plan and consider timely recommendations for improving the U.S. Development Plan.

  • 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.


More Definitions of US Development

US Development means the Development of the Products conducted hereunder for the primary purpose of supporting (whether pivotal or not) the U.S. Regulatory Approvals for the Initial Indications and/or the Joint Additional Indications, if any, irrespective of the country wherein a study thereof is conducted and irrespective whether the result of which is also used for the purpose of supporting the Regulatory Approvals in the Royalty Territory. For the purpose of this definition, Manufacturing Development shall be excluded from the U.S. Development.
US Development means Development of the Product for use in the United States.

Related to US Development

  • 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.

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

  • Land development means the erection of buildings or structures on land, or the change of use of land, including township establishment, the subdivision or consolidation of land or any deviation from the land use or uses permitted in terms of an applicable land use scheme;

  • 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:

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

  • 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.

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

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

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

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

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