Cubist Development Plan Clause Samples

Cubist Development Plan. (a) Cubist shall prepare and update annually a development plan for Licensed Products (the “Cubist Development Plan”). The Cubist Development Plan may include, as appropriate and without limitation, the following elements: (i) Cubist’s plan for conducting and completing the Required Studies; (ii) Cubist’s general strategy for developing indications other than the indications pursued in the Required Studies for use of Licensed Products throughout the world; (iii) design and execution of pre-clinical and clinical studies for indications other than the indications pursued in the Required Studies; (iv) development of improvements in formulation, presentation and other features of Licensed Products considered desirable for life cycle management and maximizing sales of Licensed Products throughout the world; and (v) an analysis of the total costs and expenses incurred or to be incurred by Cubist in connection with its development activities set forth in the Development Plan. Cubist shall update the Cubist Development Plan annually and provide such updated Cubist Development Plan to Chiron prior to the JCT’s last scheduled meeting during the then current year. Chiron shall have the right to review and comment, via the JCT, on the Cubist Development Plan and any and all revisions and updates thereto, and Cubist shall, in good faith, consider all comments made by Chiron. (b) Subject to the provisions of this Section 4.2(b), Cubist shall use Commercially Reasonable Efforts to carry out and perform during each calendar year the activities set forth in the Cubist Development Plan as may be in effect for such calendar year that are materially significant for obtaining Regulatory Approval. With the exception of the Required Studies (which Cubist may not change, modify, abandon or discontinue except in accordance with the provisions of Section 4.1 hereof), Cubist reserves the right at any time to change or modify the Cubist Development Plan or any of the preclinical studies or clinical trials described in the Cubist Development Plan, or to abandon any portion of the Cubist Development Plan or discontinue any such preclinical studies or clinical trials, in response to (i) changes in clinical or regulatory strategy, (ii) regulatory feedback, (iii) scientific feasibility, (iv) increases in the anticipated costs of clinical trials, (v) any significant adverse event or condition relating to the safety or efficacy of a Licensed Product, (vi) manufacturing feasibility, includin...