Phase I Study. The term “
Phase I Study. The term “Phase I Study” shall mean a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Phase I Study. Within twenty (20) days after the execution of ------------- this Agreement, Seller shall, at its sole expense, commission a qualified engineering firm to conduct the Study in accordance with ASTM Standard 1527-94. Within three (3) business days of receipt of the report of the completed Study, Seller shall promptly deliver the report of the Study to Buyer. Buyer shall hold the information about the Study and any related information or documentation in confidence in accordance with the provisions of Section 6.13. If Buyer notifies Seller in writing within thirty (30) Business Days from the date Buyer receives the report of the Study that the Study discloses the existence of any breach, or any facts which could be expected to result in a breach, of the representations of Seller contained in Section 4.16, Seller shall promptly commence further investigation and/or remedial action to cure the condition at its expense prior to the Closing; provided that Seller shall not be obligated to spend more than $100,000 in the aggregate in its attempt to cure all such conditions. Seller shall notify Buyer within seven (7) days after its receipt of such written notice from Buyer if Seller determines that it is or will be unable to cure such conditions for $100,000 or less. If Seller exercises the right not to cure such conditions because the aggregate cost would exceed $100,000, Buyer may elect (i) to terminate this Agreement with no cost or obligation on the part of Seller or (ii) to waive such obligations, in which event Buyer shall receive a credit at the Closing in the amount, if any, by which $100,000 exceeds the aggregate amount paid by Seller to third parties in connection with curing such conditions and assume all liabilities and obligations in connection with such conditions and hold harmless and indemnify Seller from same in accordance with this Agreement, notwithstanding any provisions, including any representations and warranties of Seller, of this Agreement to the contrary and Seller shall have no liability under this Agreement or otherwise to Buyer related to or arising from such conditions.
Phase I Study. As defined in Section 5.2.
Phase I Study. Within twenty (20) days after the execution of this Agreement, Seller shall, at its sole expense, commission a qualified engineering firm to conduct the Study in accordance with ASTM Standard 1527-94. Within three (3) business days of receipt of the completed Study, Seller shall promptly deliver the Study to Buyer. If Buyer notifies Seller in writing within thirty (30) Business Days from the date Buyer receives the report of the Study that the Study discloses the existence of any breach, or any facts which could be expected to result in a breach, of the representations of Seller contained in Section 5.12, Seller shall promptly commence further investigation and/or remedial action to cure the condition at its expense prior to the Closing; provided that Seller shall not be obligated to spend more than $50,000 in the aggregate in its attempt to cure all such conditions. Seller shall notify Buyer within seven (7) days after its receipt of such written notice from Buyer if Seller determines that it is or will be unable to cure such conditions for $50,000 or less. If Seller exercises the right not to cure such conditions because the aggregate cost would exceed $50,000, Buyer may elect (i) to terminate this Agreement without waiver of any remedies available to Buyer hereunder or (ii) to waive such obligations, in which event Buyer shall receive a credit at the Closing in the amount, if any, by which $50,000 exceeds the aggregate amount paid by Seller to third parties in connection with curing such conditions and assume all liabilities and obligations in connection with such conditions and hold harmless and indemnify Seller from same in accordance with this Agreement, notwithstanding any provisions, including any representations and warranties of Seller, of this Agreement to the contrary and Seller shall have no liability under this Agreement or otherwise to Buyer related to or arising from such conditions.
Phase I Study. From the Contract Date to March 2, 2001 (the "ENVIRONMENTAL INSPECTION PERIOD"), Buyer and its employees, agents, and third party consultants (collectively, the "BUYER'S REPRESENTATIVES") shall be entitled to enter on the Land and Improvements, at reasonable times and on reasonable notice to Seller, to perform a phase I environmental study of the Land (the "PHASE I STUDY"). Buyer shall provide not less than twenty-four (24) hours' prior telephonic notice to Seller before performing any such study.
Phase I Study. A desktop Hazardous Materials Evaluation will identify potential impacts from hazardous materials and wastes associated with the proposed project. The project area for the Hazardous Materials Evaluation report includes the project footprint plus 100 feet. The evaluation will include a preliminary review of potential hazards associated with the existing project area that may affect the environment and construction/operation of the proposed project.
Phase I Study. Two Million Dollars ($2,000,000) upon initiation of enrollment of patients for the first Phase I Study of a Licensed Product.
Phase I Study. One Million Dollars ($1,000,000) upon initiation of enrollment of patients for the first Phase I Study of a Collaboration Product.
Phase I Study. 3 1.19 Phase III Study.....................................................3
