Development Studies definition

Development Studies means any Clinical Studies that are necessary to obtain or maintain a Regulatory Approval other than Territory Specific Studies and Investigator Sponsored Studies.
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Development Studies means any Nonclinical Studies, Clinical Trials, Post-Approval Commitment (PAC) (or post-marketing requirement) Studies and Phase IV Studies in respect of BIA 9-1067 or Licensed Products carried out by or on behalf of NBIX in accordance with this Agreement.
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Development Studies means all CMC, pre-clinical and Clinical Studies identified in the Development Plan.
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Examples of Development Studies in a sentence

  • Canberra: The Australian National University, National Centre for Development Studies (Pacific Policy Paper 24).

  • Should a Party desire to conduct Further Development Studies for the Licensed Product, the Parties shall discuss the possible conduct of such development activities, including any sharing of costs.

  • PRAECIS shall supply Synthelabo with all Licensed Products required for Synthelabo to conduct the Supplemental Development Studies pursuant to the Supplemental Development Plan.

  • Cubist shall use Commercially Reasonable Efforts to complete, subject to the provisions of this Section 4.1, the Key Development Studies.

  • Grünenthal shall be required to obtain AcelRx’s consent before conducting such Further Development Studies for the Licensed Product, such consent not to be unreasonably withheld.

  • Such supply of Licensed Products shall be (i) at a price equal to PRAECIS' COGS if Synthelabo is not entitled, pursuant to Section 4.5, to receive reimbursement from PRAECIS for a portion of its Development Costs incurred in connection with such Supplemental Development Studies and (ii) otherwise charged to Synthelabo as a Development Cost pursuant to Sections 1.13 and 4.5.

  • Notwithstanding anything in this Section 4.1 to the contrary, prior to making any decision to abandon or discontinue any of the Key Development Studies, any Replacement Study or any Replacement Indication Study (each a “Required Study”), or to change or modify any Required Study so as to effectively abandon same, Cubist shall have first provided its reasons in support of such decision to Chiron via the JCT and the JCT shall have met to discuss the merits of such decision.

  • Monitoring and evaluation of project results shall include the conduct of baseline, mid- term and endline evaluations by the Philippine Institute for Development Studies, or a third-party appointed subject to IFAD no-objection.

  • Specifically, in the event that Additional Development Studies for a Licensed Product (as defined in the Development and Option Agreement) are undertaken, Verve will notify Acuitas once a formulation is selected for technology transfer.

  • Following any such replacement, Cubist shall use Commercially Reasonable Efforts to complete the Replacement Study provided that Cubist may change, modify, abandon or discontinue such study to the same extent as provided in this Section 4.1 for the Key Development Studies.


More Definitions of Development Studies

Development Studies has the meaning set forth in Section 6.2 below.
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Development Studies. As defined in Article I, Section 1.3.A.
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Related to Development Studies

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.