PREA Development Plan definition

PREA Development Plan means the written operational development plan to conduct the PREA Commitment Study as established by the JDC.”
Sample 1

Examples of PREA Development Plan in a sentence

  • For avoidance of doubt, the JDC shall not have decision-making power for any matter outside the scope of PREA Commitment Study, and notwithstanding any provision of this Agreement to the contrary, neither the JDC nor the JSC shall have the authority to alter or amend the PREA Development Plan without [****] express written consent.

  • For clarity, the Parties acknowledge and agree that the third sentence of Section 2.1.3(i) regarding escalation of certain disputes shall be inapplicable to disputes relating to the PREA Development Plan, and that [****] shall have final decision-making authority with respect to the PREA Development Plan and all regulatory interactions related thereto; provided, however, that [****] shall give good faith consideration to the input of [****] in making such decisions and in conducting such interactions.

  • The PREA Development Plan shall consider all aspects of the conduct of the trial, including but not limited to, protocol development, site selection, the use of a contract research organization, CRF and database design, and such other matters as the JDC may determine are necessary based on FDA recommendations or requirements with respect to such Study.

  • Reasonable Efforts to complete and prepare the final clinical study report for the PREA Commitment Study within the timeframe set forth in the PREA Development Plan; provided, however, [****].

  • Upon the formation of the JDC and subject in all cases to final approval by [****] the JDC shall agree upon and execute the PREA Development Plan.

  • Such PREA Development Plan shall be finalized by the JDC within [****] of the formation of the JDC.

Related to PREA Development Plan

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

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

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

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

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

  • Development Program means the implementation of the development plan.

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

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • 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.

  • 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.

  • 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 Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.