Development Program Activities Sample Clauses
The 'Development Program Activities' clause defines the specific actions, milestones, and responsibilities involved in carrying out a development program under an agreement. It typically outlines the scope of work, timelines, and deliverables required from each party, such as research, testing, regulatory submissions, or product development stages. By clearly delineating these activities, the clause ensures that both parties understand their obligations and expectations, thereby reducing the risk of misunderstandings and facilitating smooth project execution.
Development Program Activities. Following completion of each Discovery Program, TESARO shall be responsible, at its sole expense, for conducting the Development Program, which shall include without limitation all pre-IND activities, including cross-reactivity studies and pilot studies to enable GLP pharmacology/toxicology studies, GMP manufacturing, regulatory filings, clinical trials and commercialization activities with respect to one or more Development Antibodies under each Development Program.
Development Program Activities. Development and regulatory activities for Products in the Field in the Territory will be conducted as outlined in the Development Plan. For clarification, Phase IV marketing studies are not considered to be development activities. The JDC shall determine on a Calendar Quarter basis the number of FTEs of each party that will work on the Development Program during such Calendar Quarter. Any amendments or revisions to the Development Plan shall be in writing and shall require unanimous approval of the JDC. Each party, as applicable, will use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities set forth in the Development Plan, in each case in compliance with the terms of this Agreement and Applicable Laws. If a party proposes development activities for Products in the Field in the Territory, but the JDC does not reach agreement to include such development activities in the Development Plan, the parties will discuss and agree whether one party can proceed with such development activities at its own expense and, if so, on what terms the results of such development activities would be made available to the other party by the party that conducts such development activities.
Development Program Activities. AvP shall, except as provided for in Sections 3.5.1 to 3.5.4 below, be solely responsible for the global DEVELOPMENT PROGRAM activities, directly or through third parties. In accordance with the PROGRAM Plan and Budget in effect from time to time, CRUCELL shall perform the following activities in this DEVELOPMENT PROGRAM.
Step 1: Generation of new PER.C8 cell line CRUCELL shall generate, characterize, and develop a new influenza producer cell line (PER.C8). This activity shall commence with the isolation and immortalization of new human embryo retina cells and shall include all related activities up to and including establishment under GMP of a master cell bank with all necessary documentation. AvP shall work with CRUCELL to define the criteria to be used to select potential donors of the embryonic retinoblast cells to be used for PER.C8. The STEERING COMMITTEE is responsible for determining the criteria used to identify and approve PER.C8 CELLS.
3.5.2 Step 2: Development of flu vaccine manufacturing process. CRUCELL shall initiate the development of small scale (up to 100 liter bioreactor) flu vaccine upstream production process using PER.C6 CELLS based on virus propagated on the PER.C6 cell line. In accordance with AvP's manufacturing obligations as provided for hereinbelow, AvP shall use the PER.C6-developed upstream manufacturing process developed by CRUCELL for developing the final influenza vaccine manufacturing process using commercial scale bioreactors.
3.5.3 Step 3: Development of Research, Pre-clinical and Clinical Data. CRUCELL shall participate with AvP in the research and pre-clinical development activities for a pandemic FLU VACCINE PRODUCT, which activities may include generation of antigen, validation of antigen in animal models and isolation of primary influenza strains. CRUCELL shall be responsible for the additional research and development activities of FLU VACCINE PRODUCTS if these activities are required only for the CRUCELL TERRITORY and not for the AvP TERRITORY.
Development Program Activities. Subject to the terms and --------------------------------- conditions set forth herein, Medarex shall (i) conduct clinical development of the Product pursuant to the Development Plan, and (ii) for a three (3) year period commencing on the Effective Date, perform research with regard to Product manufacture improvements. Such activities shall comprise the "Development Program." Medarex shall use reasonable efforts to conduct the Development Program in accordance with the Development Plan and within the time schedules contemplated therein, and shall use reasonable efforts to comply with all submission procedures to the appropriate regulatory authorities, to respond timely to inquires of said regulatory authorities and to maintain submissions and support new submissions. Medarex shall keep the Development Committee reasonably informed of the progress of the Development Program and shall provide the Development Committee a reasonable opportunity to review and comment on trial protocols, study designs, endpoints, target patient population and other relevant factors to such trials.
Development Program Activities. Subject to the terms and conditions set forth herein, the Parties shall perform research, conduct development, and commercialize Products pursuant to the Development Plan. Such activities shall comprise the "Development Program" and shall be conducted primarily at Integ's facility. The Parties shall use reasonable efforts to conduct the Development Program in accordance with the Development Plan set by the Development Committee, and shall use reasonable efforts to comply with all submission procedures to the appropriate regulatory authorities, to respond timely to inquires of said regulatory authorities and to maintain submissions and support new submissions. The Parties shall keep the Development Committee reasonably informed of the progress of the Development Program and shall provide the Development Committee a reasonable opportunity to review and comment on Product research and development, study designs, clinical trials, submissions, launch and other relevant factors.