Development Proposal Criteria definition

Development Proposal Criteria means, with respect to a Proposed Trial, a general description of the study design, clinical study endpoints, clinical methodology, and [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. monitoring requirements, and the budget estimate of Out-of-Pocket Costs and FTE Costs associated therewith, together with an analysis of projected return on investment of such trial.
Development Proposal Criteria. Development Proposal Criteria shall mean, with respect to a Development activity, a general description of the study design, clinical study endpoints, clinical methodology and monitoring requirements and the funding budget, together with an analysis of projected return on investment of such Development activity, each as applicable. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Related to Development Proposal Criteria

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

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

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • JRC has the meaning set forth in Section 2.1.1.

  • Project Proposal is the final and written description of the Project as described in Exhibit A, to be undertaken by Sub-recipient for which the Project Funds is granted and performance is required and monitored pursuant to this PFA.

  • ASAM criteria means the most current edition of the American Society of Addiction Medicine's published criteria for admission to treatment, continued services, and discharge.

  • Design Criteria means design and construction code requirements relating to the mode of design and construction of a boiler or pressure vessel.

  • Value engineering change proposal (VECP means a proposal that--

  • Over-Riding Nomination Criteria means the criteria set out in clause 4.2.

  • Development Program means the implementation of the development plan.

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Collaborative matter means a dispute, transaction, claim, problem, or issue for resolution, including a dispute, claim, or issue in a proceeding, that is described in a collaborative law participation agreement and arises under the family or domestic relations law of this state, including any of the following:

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • JSC has the meaning set forth in Section 3.1.

  • Selection Criteria means and includes all of the requirements, considerations,

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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.

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Development Phase means the period before a vehicle type is type approved.

  • Objective medical evidence means reports of examinations or treatments; medical

  • Research Budget has the meaning set forth in Section 2.2.