Modification of the Development Plan Sample Clauses

Modification of the Development Plan. If BIOMARIN intends to substantially modify the Development Plan, BIOMARIN shall notify DSP of such intention and the Parties shall promptly discuss, in good faith, such modification; provided, however, that if the Parties are unable to reach an agreement, BIOMARIN shall have the right to make the final decision with respect to any such modifications. The Parties acknowledge that the Development Plan represents a best estimate of the activities associated with the development of a Drug Product and the timing of those activities, but that such plan is subject to substantial uncertainty and may need to be modified, as contemplated above for many reasons.
Sample 1
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Modification of the Development Plan. (a) Exhibit E sets forth the currently anticipated design of the [***]. Based on data from the Northern Trial and Southern Trial, the JSC will consider carefully the clinical and non-clinical data generated as of the relevant date of determination, as well as the evolving treatment landscape, in order to design any additional Phase I Clinical Trial(s), Phase II Clinical Trial(s) and/or pivotal Phase III Clinical Trials to evaluate P-1037 and will supplement the Development Plan accordingly, provided that:
Sample 1
Modification of the Development Plan. If BioMarin intends to substantially modify a Development Plan previously discussed with DSP, BioMarin shall notify DSP of such intention and the Parties shall promptly discuss, in good faith, such modification, provided, however, that if after such good faith discussions, the Parties are unable to reach an agreement, BioMarin shall have the right to make the final decision with respect to any such modifications and will continue to use Commercially Reasonable Efforts to develop such indications in the Other Field. The Parties acknowledge that each Development Plan represents a best estimate of the activities associated with the development of a Drug Product and the timing of those activities, but that such plan is subject to substantial uncertainty and may need to be modified, delayed or abandoned, as contemplated above for many reasons.
Sample 1

Related to Modification of the Development Plan

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Information Systems Acquisition Development and Maintenance Security of System Files. To protect City Information Processing Systems and system files containing information, Service Provider will ensure that access to source code is restricted to authorized users whose specific job function necessitates such access.

  • Post-Commercial Operation Date Testing and Modifications Each Party shall at its own expense perform routine inspection and testing of its facilities and equipment in accordance with Good Utility Practice as may be necessary to ensure the continued interconnection of the Large Generating Facility with the Participating TO’s Transmission System in a safe and reliable manner. Each Party shall have the right, upon advance written notice, to require reasonable additional testing of the other Party’s facilities, at the requesting Party’s expense, as may be in accordance with Good Utility Practice.

  • Implementation Plan The Authority shall cause to be prepared an Implementation Plan meeting the requirements of Public Utilities Code Section 366.2 and any applicable Public Utilities Commission regulations as soon after the Effective Date as reasonably practicable. The Implementation Plan shall not be filed with the Public Utilities Commission until it is approved by the Board in the manner provided by Section 4.9.

  • Implementation of Agreement Each Party must promptly execute all documents and do all such acts and things as is necessary or desirable to implement and give full effect to the provisions of this Agreement.

  • Implementation of the Agreement Regulations of this Agreement relating to investments who investors of one Contracting Party realized before or after the entry into force of this Agreement, with what shall apply from the moment of its entry into force, provided that such investments conducted in accordance with the laws of that Party Contracting.

  • Modification of Services Credit Union reserves the right to modify the Service from time to time without making prior notice to Member, provided, however, that Credit Union will give you at least thirty (30) days notice prior to making any modifications to the Service that would materially alter their functionality.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Improvement Plan A written plan developed by the evaluator, utilized when a teacher received a Rating of Ineffective on his/her Evaluation or on any individual deficiency in the evaluation system.

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