Initial Development Outline definition

Initial Development Outline is defined in Section 4.2(a).

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Initial Development Outline means the initial outline of the Development strategy for Licensed Products in the Territory attached hereto as Exhibit B.

Initial Development Outline has the meaning set forth in Section 4.1.

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.
RENTAL FEE: A rental fee equal to $125.00 is required no later than 14 days prior to the date of the event.
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 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.
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.
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.
The Clinical Development Plan shall provide for each Joint 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 both Parties in advance in writing.
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.
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...