STAGE I RESEARCH PLAN means the stage I research as described in the plan attached as Appendix A and any amendment thereto agreed to in writing by the Parties.
Research Plan shall have the meaning set forth in Section 2.1.
Development Plan has the meaning set forth in Section 3.2.
Development Program means the implementation of the development plan.
Research Program has the meaning set forth in Section 2.1.
Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.
Research Program Term has the meaning set forth in Section 2.2.
Development Phase means the period before a vehicle type is type approved.
Research Budget has the meaning set forth in Section 4.2.
Development Schedule shall have the meaning set forth in Section 1.1.
Commercialization Plan has the meaning set forth in Section 6.2.
Development Site means any parcel or lot on which exists or which is intended for building development other than the following:
Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;
Development Plans has the meaning set forth in Section 3.2.
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.
Collaboration has the meaning set forth in Section 2.1.
Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Collaboration Term has the meaning specified in Section 2.1.2 hereof.
Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.
Joint Research Committee or “JRC” has the meaning set forth in Section 3.1.1.
Initial Development Plan has the meaning set forth in Section 3.2(b).
Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).
Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.
Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.
Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.