Phase I Study Clause Samples

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. Lilly, [***], will use its commercially reasonable efforts to promptly complete the Ongoing Phase I Study, including but not limited to completing patient follow-up, data collection, data analyses, summary reports and final reports. Lilly will transfer to Isis the results generated under the Ongoing Phase I Study promptly after they become available to Lilly from the Third Party vendor assembling such data and reports, including, but not limited to, raw data, interim and final reports in a manner consistent with Section 2.3. Lilly will use its good faith efforts to (i) send Isis the raw data collected by Lilly (in the format collected by Lilly) from such Phase I Study within [***] days following the locking of the primary database for such study, and (ii) send Isis the clinical summary reports for such Phase I Study within [***] days following the locking of the primary database for such study. Except for as provided in Article 4, Lilly shall have no obligation to conduct any other development activities with respect to the eIF-4E Program or the Product.

Phase I Study. 3 1.19 Phase III Study.....................................................3

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. 8 Section 1.53 Phase II(a) Study.................................................... 8 Section 1.54 Phase II(b) Study.................................................... 8 Section 1.55 Phase III Study...................................................... 8 Section 1.56

Phase I Study. (Studies) shall mean, within the context of a given IL-13 Development Program, all tolerance studies of an IL-13 Product as well as any pharmacodynamic study relative to said IL-13 Product conducted by IDM in treated patients.