Plan Indication definition

Plan Indication means the medical condition generally described as dry eye.
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Examples of Plan Indication in a sentence

  • If Acucela concludes during or at the end of the Plan Development Phase that there is little or no possibility of obtaining the Regulatory Approval for the Product in the Plan Indication in the United States, Acucela shall notify in writing Otsuka thereof, along with detailed reason(s) therefor.

  • Otsuka shall, as soon as practicable after filling with the FDA of a NDA for the Product for the Plan Indication, and in no event more than thirty (30) days thereafter, enter into good faith exclusive negotiations with Acucela for an exclusive license (except as to Otsuka, Otsuka’s Affiliate, or Otsuka’s designee as a co-promotion partner) to co-promote the Product in the United States upon commercially reasonable terms.

  • Otsuka wishes to engage Acucela to develop a development plan for the Product, and lead the implementation of the plan with the cooperation of Otsuka, with the goal of obtaining, in Otsuka’s or its designee’s name, the FDA approval for the Product in the Plan Indication (as defined below) (the “Project”).

  • Otsuka may terminate this Agreement by giving Acucela written notice (i) if a NDA for the Product in the Plan Indication is not filed with the FDA in Otsuka’s or its designee name within * after the date presented in the Final Plan for such filing for whatever reason or (ii) if the Project Completion does not occur within * after the date presented in the Final Plan for such completion for whatever reason.

Related to Plan Indication

  • Second Indication means [***].

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.