Phase III Option definition

Phase III Option has the meaning set forth in section 2.10 (b).
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Phase III Option is defined in Section 35.01.
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Examples of Phase III Option in a sentence

  • If a KPI Default has occurred prior to the Phase III Option Date, the Phase III Option Date shall be extended until IBM has demonstrated that it has performed the Services without a KPI Default for ***.

  • Based on all those considerations, Purchaser and Seller agree that the Exxxxxx Money (together with interest on it), the Extension Payment(s) (if any), the Phase II Option Payment and the Phase III Option Payment, represent a reasonable estimate of Seller’s damages.

  • This will result in a formal design lock (i.e., freeze) in preparation for device validation to take place in contract Phase III (Option II).

  • If Purchaser does not exercise the Phase II Option in accordance with this Section 1.2(c), the Phase II Option, the Phase III Option and this Agreement shall terminate, and all further rights and obligations of the parties under this Agreement shall terminate, except those which by their terms survive any termination of this Agreement.

  • The result of this work will be the completion of the Algorithm Training Study Final Report and locking (i.e., freeze) of the ML algorithm in preparation for Algorithm Validation in contract Phase III (Option II).

  • Tenant may exercise the Phase II Expansion Option and the Phase III Expansion Option set forth in Article XXI in either order, the Phase II Option first and the Phase III Option second or vice versa.

  • The result of this work will be the completion of the Algorithm Training Study Final Report and locking (i.e., freeze) of the ML algorithm in preparation for Algorithm Validation in contract Phase III (Option 2).

  • If Purchaser does not exercise the Phase III Option in accordance with this Section 1.2(e), the Phase III Option and this Agreement shall terminate, and all further rights and obligations of the parties under this Agreement shall terminate, except those which by their terms survive any termination of this Agreement.

  • If Purchaser exercises the Phase III Option in accordance with this Section 1.2(e), then Seller shall sell to Purchaser, and Purchaser shall purchase from Seller, the Phase III Property under the terms and conditions of this Agreement.

  • Based on the Training Study data analysis, study Site device user feedback, as well as additional clinical information from non-burn clinicians and in collaboration with the clinical study Site PIs and BARDA, SMD will develop an IRB protocol for the Algorithm Validation Clinical Study that will take place in contract Phase III (Option II).

Related to Phase III Option

  • 3(i) Option means an Option granted pursuant to Section 3(i) of the Ordinance to any person who is Non- Employee.

  • Top-Up Option has the meaning set forth in Section 1.04(a).

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Shoe Option means the Initial Purchasers’ option to purchase up to seventy five million dollars ($75,000,000) aggregate principal amount of additional Notes as provided for in the Purchase Agreement.

  • Vested Option means any Option, which has already been vested according to the Vesting Dates.

  • Call Option Period has the meaning given to it in Condition 6.04 (Call Option);

  • Performance Option means an Incentive Stock Option or Nonqualified Stock Option, the grant of which or the exercisability of all or a portion of which is contingent upon the attainment of specified Performance Measures within a specified Performance Period.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Grant Year has the same meaning as in subclause 1(1) of Schedule 1 of HESA; ‘HESA’ means the Higher Education Support Xxx 0000; ‘maximum basic grant amount’ or ‘MBGA’ has the same meaning as in subclause 1(1) of Schedule 1 of HESA.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Option Term means a period, if any, through which this Agreement may be or has been extended by the JBE.

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Option Period means the period during which an Option may be exercised.

  • Vested Options means the Options that have vested in accordance with Section 2.2 of this Agreement.

  • Extension Option shall have the meaning set forth in Section 2.5(c) hereof.

  • Covered Call Option means an exchange traded option entitling the holder, upon timely exercise and payment of the exercise price, as specified therein, to purchase from the writer thereof the specified underlying Securities (excluding Futures Contracts) which are owned by the writer thereof and subject to appropriate restrictions.

  • Stock Index Option means an exchange traded option entitling the holder, upon timely exercise, to receive an amount of cash determined by reference to the difference between the exercise price and the value of the index on the date of exercise.

  • Unvested Option means an Option in respect of which the relevant Vesting Conditions have not been satisfied and as such, the Option Grantee has not become eligible to exercise the Option.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Director Option means an Option granted pursuant to Section 6.

  • Option Exercise Period has the meaning set forth in Section 6.4.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Employee Option means an Option granted pursuant to Section 5.