Additional Indication means any indication other than the Initial Indication.
Initial Indication means the use of a Product for the treatment of opioid addiction.
The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.
Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:
Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.
New Project means (a) each facility which is either a new facility, branch or office or an expansion, relocation, remodeling or substantial modernization of an existing facility, branch or office owned by the Borrower or its Subsidiaries which in fact commences operations and (b) each creation (in one or a series of related transactions) of a business unit to the extent such business unit commences operations or each expansion (in one or a series of related transactions) of business into a new market.
Project Milestone means the project milestone set forth in Schedule-J;
Development Site means any parcel or lot on which exists or which is intended for building development other than the following:
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Development Milestone Event has the meaning set forth in Section 7.2.1.
Development Schedule shall have the meaning set forth in Section 1.1.
Development Milestone is defined in Section 5.3.
Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.
Project Plan means the document to be developed by the Contractor and approved by WTL, 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 WTL. 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.
Project Milestones means the Project milestones set out in Schedule 3;
Qualifying project means (i) any education facility, including, but not limited to a school building,
Development Plan has the meaning set forth in Section 3.2.
Second Indication means [***].
Sub-project means a specific development project to be carried out by a Beneficiary utilizing the proceeds of a Sub-loan;
MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;
Expansion Project has the meaning set forth in Section IV.3.a of this Agreement.
Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Development Project means a project for the development of land within a
Project Implementation Unit or “PIU” means the unit referred to in Section I.A.2 of Schedule 2 to this Agreement.
Proposed Project SCHEDULE: (edit schedule below as appropriate) Pre-bid Meeting Questions Due Proposals Due Begin Work Programming Phase Permitting Phase Schematic Design Phase Construction Documents Phase Bidding or Negotiation Phase Construction Administration 1-Year Warranty
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.