Phase II Study Sample Clauses

The 'Phase II Study' clause defines the requirements and parameters for conducting a Phase II clinical trial within a contractual agreement. It typically outlines the objectives, endpoints, and design of the study, such as the number of participants, dosing regimens, and evaluation criteria for efficacy and safety. This clause ensures that both parties have a clear understanding of the scope and expectations for the Phase II trial, thereby facilitating regulatory compliance and aligning the parties on the study's goals and operational details.
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Phase II Study. The term “
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Phase II Study. The term “Phase II Study” shall mean a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
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Phase II Study. (Studies) shall mean, within the context of a given IL-13 Development Program, all studies conducted by IDM to demonstrate clinical activity of the IL-13 Product in treated patients.
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Phase II Study. The first step in the Product Development Plan to be developed by the JPT will be the design and implementation of a Phase II clinical trial of the Licensed Product in Hepatitis C virus-positive liver transplant patients in study sites located in the Territory and in the U.S.A. (the “Phase II Study”). The Phase II Study shall be conducted in accordance with good clinical practices applicable during the Term in both the European Union and the USA (“GCP”) to a standard appropriate for inclusion in a BLA filing in both jurisdictions. Kedrion will be responsible for the implementation and conduct according to GCP of the Phase II Study and for preparation of the final study report with respect thereto (the “Final Study Report”) provided that the JPT shall have such involvement therein as it shall elect. The first patient/first visit in the Phase II Study shall commence by the later of [*****] following completion of the procedures set out in paragraphs (a)-(d) of Section 2.4, if applicable. The Final Study Report shall be produced no later than [*****] after the date of the last patient/last visit in the Phase II Study.
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Phase II Study. After execution of this Agreement, the Seller shall give Purchaser access to the Owned Real Property for purposes of Purchaser performing a Phase II environmental study.
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Phase II Study. If the Phase I Study discloses a "recognized environmental condition" (as that phrase is defined in ASTM E1527-00 Standard Practice for Environmental Site Assessments: Phase 1 Environmental Site Assessment Process; the "ASTM STANDARDS"), then Buyer at its sole election may extend the Environmental Inspection Period for a period not to exceed sixty (60) days to enable Buyer to perform a Phase II environmental study within the meaning of the ASTM Standards (the "PHASE II STUDY"; the Phase I Study and the Phase II Study, if any, are hereinafter collectively referred to as the "ENVIRONMENTAL STUDIES"). Buyer shall make such election by notifying Seller and Escrow Agent in writing before the expiration of the Environmental Inspection Period. Buyer shall perform the Environmental Studies as soon as possible using commercially reasonable efforts. If the Environmental Studies reveal environmental conditions that are unacceptable to Buyer in the exercise of its commercially reasonable judgment, Buyer may terminate this Contract before the last day of the Environmental Inspection Period (as it may have been extended as provided in this Section 5.2) (the "APPROVAL DATE") by notifying Seller and Escrow Agent in writing (the "TERMINATION NOTICE"). On receipt of the Termination Notice, Buyer shall as a condition to the return of the Deposit, deliver to Seller true, correct, and complete copies of the Environmental Studies. On receipt of the Termination Notice by Seller and Escrow Agent, Escrow Agent shall return the Deposit to Buyer and neither party shall have any further liabilities or obligations except for those liabilities and obligations that expressly survive a termination of this Contract. If Buyer fails timely to deliver a Termination Notice to Seller and the Escrow Agent before the end of the Environmental Inspection Period (as extended, if applicable), Buyer shall be automatically deemed to have forever waived its right to terminate this Contract and receive a refund of the Deposit (except as otherwise expressly provided herein) and the Property shall be deemed acceptable to Buyer.
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Phase II Study. (i) Buyer shall engage O'Brien & Gere Engineers, Inc. ("O'Brien & Gere") to conduct soil and groundwate▇ ▇ampling and other tests, at B▇▇▇▇'s expense, in accordance with the initial sampling attached hereto as Schedule 5.11 (the "Phase II Study"). The Phase II Study shall be completed and the results provided to Buyer and Seller in draft form within 21 days of the execution of this Agreement. (ii) If the Third Party Environmental Consultant determines that the Phase II Study is not sufficient to delineate the vertical and horizontal extent of Petroleum Products in the soil and groundwater (A) on the Sites, (B) migrating off-site from the Sites or (C) migrating from off-Site sources onto the Sites, so as to allow the Third Party Environmental Consultant to perform a Risk Assessment (as defined below) and, if necessary, to determine the Costs of Remediation and Property Damage Estimates (as defined below), the parties hereto agree that additional samples may be required ("Additional Sampling"). The parties hereto agree to use their respective good faith efforts to minimize the number of samples required consistent with the goals of the Phase II Study. Any such Additional Sampling (including the locations therefor), if required, must be agreed upon by Buyer and Seller in advance and must be completed no later than 21 days after the results of the Phase II Study are provided to Buyer and Seller in draft form. The parties hereto also recognize that permission from third parties may be required to sample off-Site if Petroleum Products have migrated off-Site from either or both of the Sites. The parties hereto agree to use their respective best efforts to obtain such permission (it being understood that "best efforts" shall in no event include any payments to third parties). With respect to Store 295, the parties agree to seek such permission to sample off-Site as soon as practicable after execution of this Agreement; provided, however, if permission is not granted within 14 days after receipt of the results of the Phase II Study, the parties agree to proceed in reliance upon the then-available information.
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Phase II Study. 16 1.66 Phase III Study .......................................................................................................... 16 1.67
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Related to Phase II Study

  • 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.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Feasibility Study Buyer is granted the right to conduct engineering and/or market and economic feasibility studies of the Property and a physical inspection of the Property, including studies or inspections to determine the existence of any environmental hazards or conditions (collectively, the “Feasibility Study”) during the period (the “Feasibility Period”) commencing on the Effective Date and ending at 5:00 p.m., Central Time, on the June 3, 2010. With Seller’s permission, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours for purposes of analysis or other tests and inspections which may be deemed necessary by Buyer for the Feasibility Study. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property in connection with Buyer’s Feasibility Study; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. Seller agrees to make its representative reasonably available during normal business hours. Buyer will not alter the physical condition of the Property or conduct invasive testing without notifying Seller of its requested tests, and obtaining the written consent of Seller to any physical alteration of the Property or invasive testing. Buyer will utilize commercially reasonable diligence to conduct or cause to be conducted all inspections and tests in a manner and at times which will not unreasonably interfere with any tenant’s use and occupancy of the Property. If Buyer determines, in its sole judgment, that the Property is not suitable for any reason for Buyer’s intended use or purpose, or is not in satisfactory condition, then Buyer may terminate this Contract by written notice to Seller prior to expiration of the Feasibility Period, in which case the ▇▇▇▇▇▇▇ Money (other than the Option Money) will be returned to Buyer, and neither party shall have any further right or obligation hereunder other than as set forth herein with respect to rights or obligations which survive termination. If this Contract is not terminated pursuant to this Section 5(a), then after expiration of the Feasibility Period, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. If this Contract is not timely terminated pursuant to this Section 5(a), Buyer’s right to terminate this Contract pursuant to this Section 5(a) and any and all objections with respect to the Feasibility Study will be deemed to have been waived by Buyer for all purposes.

  • 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 or the Prospectus, or the results of which are referred to in the Registration Statement 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 EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement 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 Registration Statement or 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 or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, 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 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.

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and ▇▇▇▇▇▇▇▇▇. A detailed definition of the specific scope for Transmission Owner and Clinton and ▇▇▇▇▇▇▇▇▇ including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to ▇▇▇▇▇ and ▇▇▇▇▇▇▇ Substations on MWP-1 and the ▇▇▇▇ Substation on MWP-2. Clinton and ▇▇▇▇▇▇▇▇▇ will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and ▇▇▇▇▇▇▇▇▇ will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and ▇▇▇▇▇▇▇▇▇ will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and ▇▇▇▇▇▇▇▇▇. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and ▇▇▇▇▇▇▇▇▇. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.