Review Board has the meaning provided in Section 2.1(f)(i) of this Commercial Shared-Loss Agreement.
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 Plan has the meaning set forth in Section 3.2.
Development Phase means the period before a vehicle type is type approved.
independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;
Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.
Development Committee shall have the meaning set forth in Section 3.4.1.
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.
Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.
Development Program means the implementation of the development plan.
Research Plan shall have the meaning set forth in Section 2.1.
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
Development Plans has the meaning set forth in Section 3.2.
Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.
JMC has the meaning set forth in Section 3.01.
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.
Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Project Team means Owner, Contractor, A/E and consultants, any separate Contractors employed by Owner, and others employed for the purpose of programming, design, and construction of the Project. The members of the Project Team will be designated in writing by Owner and may be modified from time to time in writing by Owner.
Commercialization Plan has the meaning set forth in Section 6.2.
JSC has the meaning set forth in Section 3.1.
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Development Site means any parcel or lot on which exists or which is intended for building development other than the following:
Benchmark Review means a review of the Services carried out in accordance with paragraphs 2.1 to 2.3 of Schedule 7 (Value for Money) of this Framework Agreement to determine whether those Services represent Good Value;
Institutional Review Board or “IRB” means, in accordance with 45 C.F.R. Part 46, 21 C.F.R. part 56, and other applicable regulations, an independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the Human Subjects involved in a study.
Project Steering Committee means the committee referred to in Section I.A.1 of Schedule 2 to this Agreement.