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

  • 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.

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

  • 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.

  • Except as specified in Section 3.B(b)(iii) of this Article IV, nothing herein shall limit the right of the Company to purchase any of its outstanding shares in accordance with law, by public or private transaction.

  • Later, another experiment showed that the semi- conductor behavior holds up to 100nm scale [14].

  • The cost of Vector Supply for Development will be included in the U.S. Development Costs, subject to adjustment as provided therein.

  • 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.

  • The JGC will seek to coordinate and harmonize the U.S. Development Plan and the ROW Development Plan.

  • In the Alonso (1960) model of land rents, value above opportunity cost does not arise from an absolute limit on the quantity of developable land, but rather through differentiation of better and worse locations.

  • To the extent such transfer is not timely made, the time period of any delay in transfer shall toll the timeline for Development of the OBD Chronic Product as set forth in the applicable U.S. Development Plan.


More Definitions of US Development

US Development means Development of the Product for use in the United States.
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.

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.

  • 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.

  • 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.

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

  • 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;

  • Substantial development means any development of which the total cost or fair market value exceeds two thousand five hundred dollars, or any development which materially interferes with the normal public use of the water or shorelines of the state; except that the following shall not be considered substantial developments for the purpose of this chapter:

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

  • 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;

  • Professional development means training programs for

  • 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:

  • Housing development as used in this section, means a development project for five or more residential units, including mixed-use developments. For the purposes of this section, “housing development” also includes a subdivision or common interest development, as defined in Section 4100 of the Civil Code, approved by a city, county, or city and county and consists of residential units or unimproved residential lots and either a project to substantially rehabilitate and convert an existing commercial building to residential use or the substantial rehabilitation of an existing multifamily dwelling, as defined in subdivision (d) of Section 65863.4, where the result of the rehabilitation would be a net increase in available residential units. For the purpose of calculating a density bonus, the residential units shall be on contiguous sites that are the subject of one development application, but do not have to be based upon individual subdivision maps or parcels. The density bonus shall be permitted in geographic areas of the housing development other than the areas where the units for the lower income households are located.

  • 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;

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

  • Development Officer means the Development Officer appointed by the Council of the Municipality.

  • 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 that meets the needs of the present generation without compromising the ability of future generations to meet their own needs;

  • 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;

  • 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.

  • land development application means the application for a land development permit on a form provided by [local jurisdiction] along with the supporting documentation required in Section [Y]-10(a).

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

  • Economic development incentive means a financial incentive,

  • 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.

  • Next Michigan development corporation means that term as defined in section 3 of the next Michigan development act, 2010 PA 275, MCL 125.2953.