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 Sunset Specific Plan.
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 The terms and conditions as set out in clause 34 onwards which apply in respect of the specific Equipment hired by the Customer.
Second Indication means [***].
geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.
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 Milestone is defined in Section 5.3.
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,
Licensed service area means the geographic area in which
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
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 shall have the meaning set forth in Section 9.2(a).
New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.
Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).
Development Plan has the meaning set forth in Section 3.2.
Indication means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition. For the avoidance of doubt, all variants of a single disease or condition (whether classified by severity or otherwise) shall be treated as the same Indication.
Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).
Licensed Territory means worldwide.