Initial Trial definition

Initial Trial has the meaning set forth in Section 2.1.1, below.
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Initial Trial shall have the meaning set forth in Section 2.1(a) of this Agreement.
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Initial Trial means the first operation of the individualequipment;
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Examples of Initial Trial in a sentence

  • If an employee is terminated from his or her promotional position after 2 completing his or her Initial Trial Service period, he or she has return rights to the classification 3 from which he or she promoted unless dismissed for just cause.

  • If a newly appointed employee is promoted during his or her initial twelve (12) 27 month Trial Service period (hereinafter "Initial Probationary Period"), his or her Initial Trial 28 Service period shall terminate twelve (12) months from the date the employee began work in 29 the classification from which he or she was promoted.

  • The Parties will also use good faith efforts to consult with each other and to finalize the Protocol for the Initial Trial for Renal Cell Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit B and the Protocol for the Initial Trial for Hepatocellular Carcinoma based on the draft clinical protocol synopsis set forth in Exhibit C) as promptly as practicable after the Effective Date.

  • Protocol, including the Protocol for the Initial Trial, shall be approved by the JDC unless the corresponding budget is also approved by the JDC either in advance of the approval of the Protocol or contemporaneously with the approval of the Protocol.

  • The Promotional Trial Service period extends six (6) months from the date 31 of the promotion or until the end of the Initial Trial Service period, whichever is later.

  • A trial overview (“Trial Overview ”) for the Initial Trial is attached hereto as Exhibit A, which shall be used by BioXcel for the drafting of the Protocol for the Initial Trial, for submission to the JDC.

  • The Promotional Trial Service period extends six (6) months from the date 2 of the promotion or until the end of the Initial Trial Service period, whichever is later.

  • To facilitate conduct of the Initial Trial, prior to the start of the Research Program, Histogen, in collaboration with Amerimmune, shall have filed a Research IND with the FDA seeking approval of a clinical trial protocol to govern the conduct of the Initial Trial.

  • A Trial Service employee who is terminated for performance deficiency related to 11 knowledge, skills, or abilities in the final six (6) months of their Initial Trial Service period, and 12 who has not received at least one Performance Review in their first six (6) months of regular 13 status employment and at least one additional Performance Review sixty (60) days or more 14 after the first Review, shall be granted severance pay in the amount of two (2) weeks of base 15 pay at their FTE and schedule.

  • The length of an employee’s Initial Trial Service period may not be 8 extended by a Memorandum of Agreement under the terms of Article 26, unless the employee 9 was absent from work for a period of forty-five (45) days or more previous to the extension.

Related to Initial Trial

  • Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.