Global Development Program Sample Clauses
The Global Development Program clause establishes the framework and objectives for an organization's international development initiatives. It typically outlines the scope of activities, geographic regions covered, and the types of projects or partnerships involved, such as capacity-building efforts, infrastructure development, or educational outreach in multiple countries. By clearly defining the parameters and expectations for global development work, this clause ensures coordinated efforts, resource allocation, and alignment with the organization's broader mission, ultimately facilitating effective and accountable international engagement.
Global Development Program. Following the selection of a Clinical Candidate in accordance with Section 2.6 above, Amgen shall develop a global development program (“Global Development Program”) to carry out the development of such Product in accordance with the Global Development Plan. The Global Development Program shall include clinical, manufacturing and other activities necessary to bring the applicable Product to market. Amgen shall notify Array regarding material changes to the Global Development Plan.
Global Development Program. Subject to Section 4.2, Trius shall use Commercially Reasonable Efforts to conduct, or have conducted, those development and registration activities with respect to Product as are necessary to obtain Regulatory Approval for Product in the U.S. in the Core Indications, including, without limitation, the completion of the Trius 113 Trial and the activities necessary to generate the information required for the CMC section of the U.S. NDA for Product and the issuance of a Certificate of Pharmaceutical Product (CPP) for each of the Core Indications by the FDA or EMA whichever can be obtained first, all as set forth in a written plan (the “Global Development Plan”), the initial form of which has been agreed upon in writing by the parties by letter agreement dated as of the Effective Date. For clarification, although the Trius 113 Trial is part of the Global Development Plan, the costs of the Trius 113 Trial shall not be included in Global Development Costs, and Trius shall be solely responsible for such costs. As part of this Global Development Plan, Trius shall undertake to complete the CMC activities as required for obtaining the clinical trial application (CTA) for China as set out in detail in Exhibit D hereto. Bayer shall provide reasonable cooperation and informal assistance to Trius in connection with that portion of any Global Development Plan activity that Trius conducts in the Bayer Territory as provided for in the Global Development Plan. In addition, Trius shall […***…], subject to JSC approval, on a case-by-case basis, of (1) […***…], (2) […***…], and (3) […***…]. The parties shall use Commercially Reasonable Efforts to design the Global Trial in Pneumonia, as such Global Trial is described in the initial Global Development Plan, in a manner calculated to be acceptable to each of FDA, EMA and SFDA, within the timelines set out in the Global Development Plan, and to amend or update the Global Development Plan from time to time as reasonably required (as determined in good faith by the JSC) to meet the requirements of FDA, EMA and SFDA.
Global Development Program. The Parties intend to Develop the Product for the Initial Indication and each Additional Indication that is included in a Development Plan, and, if VIT exercises the CKD Option, in CKD, for the purpose of obtaining Regulatory Approval for the Product in each such Indication in the EU, in the Territory outside the EU and in the U.S. Accordingly, the Parties shall consult with the EMA and FDA with respect to the Development strategy for the Product, including requesting scientific advice from the EMA, and will take into account all scientific advice from the EMA, to the extent such advice can be technically implemented, and other reasonable requirements, recommendations and guidance from such Regulatory Authorities in preparing the Development Plans. Furthermore, to the extent not materially affecting the costs or timeline of Development pursuant to the first sentence of this Section 4.2, the Parties may consult with other relevant Regulatory Authorities in the Territory with respect to the Development strategy for the Product and shall use Commercially Reasonable Efforts to address any requirements, recommendations and guidance from such Regulatory Authorities in the Development Plans.
Global Development Program. As between the Parties, Kite shall […***…]. Subject to Section 4.8.3, if DS exercises its Option for a Opt-in Product […***…] by Kite for such Opt-in Product (i.e., within […***…] of such date), then […***…] of such Product, the Parties shall discuss in good faith whether to include the Territory as part of a global development program for such Opt-in Product, and if so, how DS will participate in such global development program. For clarity, if the Parties agree to include the Territory in a global development program, DS shall […***…].
Global Development Program. (a) As between the parties, Dermavant shall be solely responsible for conducting, [***] non-clinical, clinical or any other development activities with respect to the Products in the Field to support MAA filing and Regulatory Approval for Products in the Existing Formulation at a [***] dosage for Atopic Dermatitis and Psoriasis in
Global Development Program. The Parties intend to Develop the Product for the Initial Indications and each Additional Indication that is included in the Development Plan for the purpose of obtaining Regulatory Approval for the Product in each such Indication in the EU and in the U.S. Accordingly, the Parties will consult with the EMA and FDA with respect to *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.