Additional Indication means any indication other than the Initial Indication.
First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.
Specific Plan means the Village 1 Specific Plan adopted by the City Council on November 27th, 2012 as set forth in Recital F.2(b).
Development Schedule shall have the meaning set forth in Section 1.1.
Initial Indication means the use of a Product for the treatment of opioid addiction.
Specific Terms in relation to a Loan means the specific terms applicable to that Loan as set out in the document entitled ‘Specific Terms’ related to that Loan;
Second Indication means [***].
Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.
geographical indication means an indication which identifies a spirit drink as originating in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of that spirit drink is essentially attributable to its geographical origin;
Development Candidate means a pre-clinical Licensed Product which possesses desirable properties of a therapeutic agent for the treatment of a clinical condition based on in vitro and animal proof-of-concept studies.
Development Milestone has the meaning set forth in Section 7.3.3.
Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;
Selection Criteria means and includes all of the requirements, considerations,
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Renewal Application means a document used to collect pertinent data for renewal of permits
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Notice of commencement means a notice required under Section 38-1b-201 for a government project, as defined in Section 38-1b-102.
Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.
inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;
Time for Completion means the time for completing the Works as stated in the Contract Data (or as extended under Sub-Clause 7.3), calculated from the Commencement Date.
Development Milestone Payment has the meaning set forth in Section 5.2.2.
Phase 2 Trial means a clinical trial of a Product on patients, including possibly pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such Product is safe for its intended use and to obtain sufficient information about such Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 C.F.R. § 312.21(b).
Development Plan means that information and those requirements for a development set forth in section 16.
Indication means any human disease or condition, or sign or symptom of a human disease or condition.
Position indicating device means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
Phase 1 Trial means a human clinical trial of a Product in any country that satisfies the requirements of 21 C.F.R. § 312.21(a), or its foreign equivalent.