Please Initial Client also expressly indemnifies GPT for any future liabilities, either administrative, civil, or criminal related to the improper use by Client or its assigns of any and all documentation that is provided to Client by GPT pursuant to this Agreement. Please Initial: ___________ Client hereby further agrees to indemnify GPT against any action, suit, claim or proceeding, whether civil, criminal or administrative, and against any fine, cost, levy, expense, judgment or award arising therefrom (collectively a "Claim"), in which GPT may be involved (whether as a witness or a party) as a result of any application or document filed or processed by GPT, on the Client's behalf, which contains any false or misleading statement or omission of material fact or which, other than through gross negligence of GPT, violates any statute, rule or order of any Federal, state or self-regulatory authority. Client agrees that GPT shall have no responsibility to verify the accuracy or adequacy of any statement, document, fact or information provided to GPT by Client or Client's attorney, accountant, representative or agents.
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).
Fixed term tenancy means a tenancy that has a fixed term of existence, continuing to a
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 [***].
Contract Term Extension means an extension of the term of this contract, at the request of Purchaser, under this Subsection. This Subsection does not obligate Contracting Officer to grant Contract Term Extension. When such extension is made, Forest Service shall make an appraisal using standard Forest Service methods and appraisal data in effect 45 days prior to the original Termination Date. Bid Premium Rates shall be added to such appraised rates to establish Flat Rates or Tentative Rates for the extension period. In event rates so established would develop Current Contract Value immediately prior to such an extension that is less than Current Contract Value at that time, Flat Rates and Tentative Rates in effect immediately prior to extension shall be retained for the extension period. In consideration for granting an extension, Purchaser shall pay the Government for Purchaser’s failure to cut and remove timber meeting Utilization Standards prior to Contract Term Extension, an amount that shall be the total of the costs to the Government resulting from the delay in harvest of Included Timber. Such costs will be determined by Forest Service and shall include, but not be limited to, the following:
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.
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,
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.
Phase III Trial means a clinical trial of a Licensed Product in human patients, which is designated as a Phase III Trial or a pivotal trial and is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) to be, either by itself or together with one or more other clinical trials having a comparable design and size, the final human clinical trial in support of Regulatory Approval of the Licensed Product, and (d) consistent with 21 CFR § 312.21(c) (as hereafter modified or amended) and any of its foreign equivalents.
Academic term means a division of the school year during which a course of studies is offered, and includes a semester, quarter, or single consolidated summer term as defined by the institution.
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 8.2.
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.