Initial Development Outline definition

Initial Development Outline is defined in Section 4.2(a).
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Initial Development Outline means the initial outline of the Development strategy for Licensed Products in the Territory attached hereto as Exhibit B.
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Initial Development Outline has the meaning set forth in Section 4.1.
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Examples of Initial Development Outline in a sentence

  • For further clarity, in agreeing to the Development Plan, HGS shall have final decision making authority (in accordance with Section 3.4) over any changes and deviations from the Initial Development Outline.

  • Notwithstanding the preceding sentence, Salix shall not make any change to the Development Plan that would have the effect of making the Development Plan inconsistent with the Initial Development Outline except following consultation with Progenics through the Committees and subject to Section 3.5(c).

  • Such Development Plan shall be consistent with the Initial Development Outline, including all timelines set forth therein, and shall set forth the objectives and planned tasks for the Development of Products for the Territory.

  • EXHIBIT C Initial Development Outline *** *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.

  • Each Development Plan shall provide for each Local Study, Joint Global Study, investigator sponsored trial and registry study to be conducted in the Territory and shall at least contain the Development activities set forth in the Initial Development Outline, unless otherwise approved by Agios in advance in writing.

  • Such plan must be consistent with the Initial Development Outline and will include anticipated timelines, budget, strategy, and the respective roles and responsibilities of each Party with respect to the activities covered by such plan.

  • EXHIBIT C Initial Development Outline *** *** INDICATES TWO PAGES OF MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.

  • Abgenix will use Commercially Reasonable and Diligent Efforts to develop or have developed on its behalf a process for the manufacture of bulk Licensed Product and to scale up that process to a scale sufficient to manufacture and supply the demand for Licensed Products anticipated in the Initial Development Outline.

  • Such Development Plan shall be consistent with the Initial Development Outline, including all timelines set forth therein, and shall set forth the objectives and planned tasks for the conduct of Development activities in connection with Commercialization of Lumacan Products in the Salix Territory.

  • Attached hereto as Exhibit D is an initial proposed outline for the development plan as of the Effective Date (the "Initial Development Outline") which shall be reviewed and revised as soon as practicable by the Steering Committee and Clinical Development Committee as soon as those entities are constituted.


More Definitions of Initial Development Outline

Initial Development Outline means the initial plan for the Development of ABX-CBL to treat GVHD, as agreed to by the Parties concurrently with the execution of this Agreement and attached hereto as Exhibit D. "IND" means an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder ("FD&CA") by the FDA or the equivalent application to the Regulatory Agency in any other country or group of countries, the filing (and approval of or right to proceed under, as applicable) of which is necessary to commence human *clinical testing of Licensed Product. "Licensed Product" means (a) a product incorporating ABX-CBL or (b) a product incorporating a CD147 Antibody to the extent Abgenix and SangStat have agreed to jointly develop and commercialize such CD147 Antibody pursuant to Article 6, including any formulation, put-upon dosage form thereof. "Major Market" means each of United States, Japan, France, Germany, the United Kingdom, Italy and Spain. "Manufacturing Overhead" means the following indirect costs, (a) all of which shall be determined in accordance with allocation principles established by mutual agreement of the Parties (b) shall be in accordance with generally accepted accounting principles and consistently applied, (c) shall be allocated to products based on methodologies consistently applied in the cost accounting system mutually agreed upon by the finance representatives from the Parties: (i) Manufacturing facility overhead including depreciation of capital, indirect supplies, indirect labor (such as product quality assurance and maintenance) utilities, insurance, property taxes and other facility costs, and all other indirect costs of the manufacturing facility including utilities, manufacturing. "Marketing Expenses" means the actual costs and expenses incurred by a Party or for its account specifically attributable to the marketing of a Licensed Product, to the extent generally consistent with the then-current Commercialization Plan and Commercialization Budget, including but not limited to [ * ] and other similar activities related to the Licensed Products and approved by the Steering Committee or its designee. Such costs will include [ * ]. "Marketing Expenses" shall also include activities related to [ * ]. "Marketing Expenses" will specifically exclude the [ * ]. "Medical Education Expenses" means the actual costs and expenses incurred by a Party or for its account specifically attributabl...
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Related to Initial Development Outline

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

  • 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.

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

  • Development Phase means the period before a vehicle type is type approved.

  • 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.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Commencement of Development means the date on which any material operation (as defined in Section 56(4) of the Act) forming part of the Development begins to be carried out other than (for the purposes of this Deed and for no other purpose) operations consisting of site clearance, demolition work, archaeological investigations, investigations for the purpose of assessing ground conditions, remedial work in respect of any contamination or other adverse ground conditions, diversion and laying of services, erection of any temporary means of enclosure, the temporary display of site notices or advertisements and “Commence Development” shall be construed accordingly.

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

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

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

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

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

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • 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.

  • 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.

  • 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.