Implementation of Development. The County will use good faith efforts to refer to and use the approved Implementation Policies and Procedures Manual for the Specific Plan to assist the County in implementing and performing its supplemental planning and administrative tasks contemplated by this Agreement. Such manual is intended to provide a comprehensive approach for processing approvals and issuing permits for all Subsequent Entitlements for development within the Plan Area. In the event of any inconsistency between the terms of this Agreement and the Implementation Policies and Procedures Manual, the terms of the Agreement shall prevail. Within ninety (90) days from the Effective Date of this Agreement, the Developer will submit an update to the Implementation Policies and Procedures Manual for review by the County pursuant to the terms of this Agreement at its sole cost and expense.
Implementation of Development. CONFORMA shall have the sole responsibility for conducting the clinical Development in the Territory. The cost of clinical Development in the Territory shall be borne by CONFORMA. The cost of non-clinical Development activities in the Territory initiated by CONFORMA after the Effective Date shall be borne by CONFORMA. CONFORMA undertakes to give SUMITOMO progress reports of the Development on a semi annual basis covering items such as the status of recruitment and registration of the patients, the result of each trial and the status of preparation of the regulatory documents for IND or NDA. It is understood and agreed that SUMITOMO has a right to participate in the investigators meetings held in the Territory and in the meetings with Regulatory Authorities in the Territory, provided that SUMITOMO’s participation shall be passive and without a right to comment.
Implementation of Development. (a) In TERRITORY A, the JDC shall determine those operational areas relating to the DEVELOPMENT for which each Party is responsible (e.g., those clinical trials for which Coulxxx xxxl have responsibility and those for which SB will have responsibility [*]), consistent with the then current JOINT DEVELOPMENT PLAN and the PLANNED CLINICAL TRIALS. The Parties agree that Coulxxx xxxl have responsibility for conducting the PLANNED CLINICAL TRIALS in TERRITORY A, unless otherwise agreed by the JDC. A Party which has responsibility for a particular operational area relating to the DEVELOPMENT in TERRITORY A shall make and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
