Development Candidate Identification Plan definition

Development Candidate Identification Plan has the meaning set forth in Section 3.5.1.
View Source
Development Candidate Identification Plan has the meaning set forth in Section 2.2.1. Confidential
View Source

Examples of Development Candidate Identification Plan in a sentence

  • For so long as Praxis’ Option has not expired or been terminated, and subject to the terms and conditions of this Agreement, Ionis hereby grants to Praxis a non-exclusive, worldwide license under the Ionis Core Technology Patents, the Ionis Manufacturing and Analytical Patents and Ionis Manufacturing and Analytical Know-How solely to perform Praxis’ Research and Development obligations and activities under the Research Plan and Development Candidate Identification Plan prior to Option exercise.

  • Ionis will carry out its drug discovery efforts in accordance with the Development Candidate Identification Plan and in a manner consistent with its internal practices for other gene targets with the goal of identifying the optimal Compound as the Development Candidate and at least one Related Compound as soon as practicable.

  • Within [***] after approval by Ionis’ research management committee (“RMC”) of a Development Candidate under the Development Candidate Identification Plan, Ionis will provide to the JSC a Development Candidate Data Package.

  • If Ionis’ RMC determines that there are no suitable Related Compounds, Ionis will include in the Development Candidate Data Package the data resulting from the final monkey screening study performed under the Development Candidate Identification Plan, if such data is not already included in the Development Candidate Data Package.

  • No later than [***] after submission of the Development Candidate Identification Plan to the JSC, the JSC will agree on the final Development Candidate Identification Plan, which plan will be consistent with Ionis’ other plans for other gene targets.

  • From time to time during the Collaboration Term Ionis will update the Development Candidate Identification Plan as needed and submit it to the JSC for its review and approval in accordance with Section 4.1.2. If the JSC cannot agree upon any aspect of the final Development Candidate Identification Plan or any update thereto proposed by Ionis within [***] following discussion at the meeting of the JSC, then either Party may refer the matter to the Senior Representatives for resolution.

  • For each Collaboration Target, an ASO Development Candidate Identification Plan and Initial Development Plan will be established pursuant to Section 1.10.1 and Section 1.10.2(d), respectively.

  • If the Senior Representatives cannot agree on any aspect of the final Development Candidate Identification Plan or any proposed update thereto within an additional [***] after the matter is so referred, then Ionis will have final decision-making authority with respect to any elements of the Development Candidate CONFIDENTIAL Identification Plan to which the Senior Representatives cannot agree.

  • Depending on the stage of development of the applicable Product at the time of such notice, to the extent known by a Party at the applicable time, such information will also be included in the applicable Target Sanction Plan or Development Candidate Identification Plan, as applicable.

  • To facilitate the activities under the Research Plan or the Development Candidate Identification Plan, either Party may provide to the other Party certain materials for use by the other Party in furtherance of the conduct of the activities under the Research Plan or the Development Candidate Identification Plan, as applicable.

Related to Development Candidate Identification Plan

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

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

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).