The initial Aspiration Designated Program Team Member shall be the individual set forth on Schedule 4.18(b).
Aspiration shall have the right, at any time, to appoint a new Aspiration Designated Program Team Member in lieu of the foregoing Person.
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.
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 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.
Joint Research Committee or “JRC” has the meaning set forth in Section 3.1.1.
Development Plan has the meaning set forth in Section 3.2.
Project Steering Committee or “PSC” means the committee referred to in Section I.B of Schedule 2 to this Agreement;
JRC has the meaning set forth in Section 2.2.
Development Program means the implementation of the development plan.
Development Committee has the meaning set forth in Article 3 of the Amended and Restated Research and Development Agreement.
JDC has the meaning set forth in Section 3.2.
JSC has the meaning set forth in Section 3.1.
JCC has the meaning set forth in Section 3.1.
Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).
Research Program Term has the meaning set forth in Section 2.2.
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)).
Research Plan shall have the meaning set forth in Section 2.1.
Commercialization Plan has the meaning set forth in Section 6.2.
Joint Steering Committee or “JSC” has the meaning set forth in Section 3.1.
JMC has the meaning set forth in Section 3.2(a).
Team Member means an individual who is allowed to access the Cloud Service but is only granted membership in groups associated with “Team Member” permissions for the Cloud Service.2
Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
Research Committee shall have the meaning set forth in Section 2.1.
Research Program has the meaning set forth in Section 3.1.
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.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).