Completion of U.S. Phase III Trial Sample Clauses

Completion of U.S. Phase III Trial. Upon the first completion of a Phase III trial of the Compound and/or Product in the United States by or under authority of XenoPort, Astellas shall pay XenoPort Five Million Dollars (US $5,000,000). As used herein, “completion” of a Phase III trial shall be deemed to occur upon the earliest of (a) receipt by XenoPort of the final report for such Phase III trial, (b) filing of an MAA for the Product or (c) first issuance of a press release by XenoPort or its licensee announcing completion of a Phase III trial of the Compound and/or Product in the United States, the date of which XenoPort shall inform Astellas in writing.
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Related to Completion of U.S. Phase III Trial

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Phase 2 Phase 2 is expected to consist of Member Nodes and a select number of Nodes operated by non-Members. The non-Member Nodes will be required to comply with Node hosting terms as set forth by the Council, which may be amended from time to time (the “General Node Terms”).

  • Production Phase contract period in which the Development and the Production are to be performed.

  • Design Development Phase INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE 1.1.6.1. The ARCHITECT/ENGINEER shall prepare from the approved Schematic Design Studies, the Design Development Documents consisting of drawings (including at least architectural, landscaping, civil, structural, mechanical and electrical plans, building sections; and finish schedule), outline specifications following the Construction Specification Institute "CSI" Format and other necessary documents to fix and describe the size and character of the entire Project as to its site, structural, mechanical, and electrical systems, materials and other such essentials as may be appropriate, for and until approved by the State. 1.1.6.2. The ARCHITECT/ENGINEER shall conduct meetings with the State, Efficiency Vermont, and relevant members of the design team, to review the Design Development Documents for the purposes of furthering the energy efficiency objectives of the Project. 1.1.6.3. The ARCHITECT/ENGINEER shall prepare for the State a revised accounting of how the Project is responding to LEED criteria. 1.1.6.4. The ARCHITECT/ENGINEER shall submit to the State a revised Statement of Probable Construction Cost based thereon for and until approved by the State.

  • Project/Milestones Taxpayer provides refrigerated warehousing and logistic distribution services to clients throughout the United States. In consideration for the Credit, Taxpayer agrees to invest in a new refrigeration and distribution facility in the XxXxxxxxx Park area of Sacramento, California, and hire full-time employees (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit A (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full-time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by Taxpayer for the entire taxable year shall be annualized. In addition, the salary of any full-time employee hired to fill a vacated position in which a full-time employee was employed during Taxpayer’s Base Year shall be disregarded.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Completion of Concrete Pours and Emergency Work (a) Except as provided in this sub-clause an Employee shall nor work or be required to work in the rain. (b) Employees shall not be required to start a concrete pour in Inclement Weather. (c) Where a concrete pour has been commenced prior to the commencement of a period of Inclement Weather Employees may be required to complete such concrete pour to a practical stage and for such work shall be paid at the rate of double time calculated to the next hour, and in the case of wet weather shall be provided with adequate wet weather gear. (d) If an Employee’s clothes become wet as a result of working in the rain during a concrete pour the Employee shall, unless the Employee has a change of dry working clothes available, be allowed to go home without loss of pay. (e) The provisions of clauses 32.7(c) and 32.7(d) hereof shall also apply in the case of emergency work where the Employees concerned and their delegates agree that the work is of an emergency nature and can start and/or proceed.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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