Phase II Study. The term “
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 equivalents thereof.
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.
Phase II Study. (i) Buyer shall engage O'Brien & Gere Engineers, Inc. ("O'Brien & Gere") to conduct soil and groundwatex xampling and other tests, at Bxxxx'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.
Phase II Study. 16 1.66 Phase III Study .......................................................................................................... 16 1.67
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.
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.
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.
