Non-Required Development Sample Clauses

Non-Required Development. (i) If either Party desires to conduct additional clinical trials or other development work on the Initial Product to enhance or expand the Regulatory Approval for the Initial Product in the Territory beyond the scope of the Initial Product NDA (but not for a new Indication), or for the purpose of enhancing scientific knowledge and understanding of the clinical utility of the Initial Product, or for any other appropriate purposes that is not Pre-Approval Required Development or Post-Approval Required Development (“Non-Required Development”), the Party desiring to conduct such Non-Required Development shall promptly notify the other Party, and the Parties shall promptly meet to discuss in good faith and seek to agree on the terms under which the Parties would conduct such Non-Required Development, including (A) the Parties’ responsibilities for conducting such Non-Required Development and (B) the sharing of Development Expenses with respect to such Non-Required Development and, if the Parties agree on such terms, the Parties shall, through the JDC, establish a Development Plan for such Non-Required Development consistent with Section 3.4. For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required Development and shall instead, to the extent agreed under Section 3.3, be considered development of an Additional Product; provided that a label expansion or amendment for the Initial Product based on results of the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Effective Date shall not be considered an Additional Product. (ii) If the Parties, through the JDC, fail to agree on a Development Plan covering any Non-Required Development within a reasonable time period (not to exceed 90 days after notice from the applicable Party), Arena shall have the right, but not the obligation, to conduct such Non-Required Development at its own expense and in its sole discretion subject to Section 3.7. (iii) Neither Party shall be required to conduct or fund any Non-Required Development, except as set forth in a Development Plan.
Sample 1
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