Development Candidate Designation Sample Clauses
The Development Candidate Designation clause defines the process by which a particular compound or product is formally selected as a 'development candidate' for further advancement in a research or development program. Typically, this clause outlines the criteria, procedures, and responsible parties involved in making the designation, such as requiring certain preclinical results or committee approvals before a candidate is chosen. Its core practical function is to establish a clear and agreed-upon milestone that triggers subsequent development activities, resource allocation, or contractual obligations, thereby ensuring both parties are aligned on when a project moves from discovery to development.
Development Candidate Designation. The Parties acknowledge and agree that, as of the Effective Date, IPI145 and IPI443 are Licensed Compounds and Development Candidates. Infinity may, in its discretion, provide to Intellikine’s in-house patent counsel a written notice of the chemical structure for any Licensed Compound following the date on which such Licensed Compound becomes a Development Candidate. Intellikine’s patent counsel may disclose such information pursuant to the last sentence of Section 12.1 solely on a need-to-know basis to Intellikine’s and its Affiliates’ employees, agents, contractors, consultants and advisers who need to know in order to respect the research exclusivity granted to Infinity pursuant to Section 2.1(d).
Development Candidate Designation. (i) Within [***] days following Ionis’ delivery of a Development Candidate Data Package with respect to a Collaboration Program to Biogen pursuant to Section 1.8.3(a) (which period will begin upon resolution of any dispute regarding omissions or deficiencies with respect to such Development Candidate Data Package in accordance with Section 1.8.3(a), including the delivery of information to resolve such omissions or deficiencies, if applicable), the Neurology JDC will discuss whether to designate the Compound proposed by Ionis as the Development Candidate (or any Related Program Compounds) as the lead Development Candidate for such Collaboration Program, taking into account the input of the [***] with respect to its [***] assessment of such proposed Development Candidate and Related Program Compounds. Any designation of a Development Candidate for a Collaboration Program by the Neurology JDC will be documented in the written minutes of the Neurology JDC. If the Neurology JDC mutually agrees to designate the Compound recommended by Ionis as the lead Development Candidate or any Related Program Compound as a Development Candidate for a Collaboration Program, then the Parties will conduct the IND-Enabling Toxicology Studies for such selected Development Candidates under the applicable Toxicology Strategy that has been agreed to in accordance with Section 1.8.3(c).
(ii) If the Neurology JDC cannot agree as to whether to designate any Compound proposed by Ionis as the lead Development Candidate or Related Program Compound as Development Candidates within [***] days after the Neurology JDC meets to discuss the applicable Development Candidate Data Package (such [***]-day period for a Collaboration Program, the “Development Candidate Decision Period”), then Biogen will have final decision-making authority as to whether to designate any such proposed Development Candidate or Related Program Compound as a Development Candidate for such Collaboration Program and Biogen will notify the Neurology JDC in writing of its determination.
(iii) If the Neurology JDC (or Biogen through the exercise of its final decision-making authority) does not designate any of the Ionis-proposed lead Development Candidate or Related Program Compounds as Development Candidates for a given Collaboration Program within the Development Candidate Decision Period, and Biogen has not cured such failure to designate a Development Candidate within the earlier of [***] days following the missed deadl...
Development Candidate Designation. If the JSC determines that an Epigenomic Controller-LNP Candidate that is Developed under the R&D Plan satisfies the Development Candidate Criteria, then such Epigenomic Controller-LNP Candidate shall be the Development Candidate under this Agreement. Without limiting the foregoing, [***]. Upon designation of an Epigenomic Controller-LNP Candidate as the Development Candidate, all Collaboration Epigenomic Controllers other than the Collaboration Epigenomic Controller used in such Development Candidate (the “Program Epigenomic Controller”) shall be deemed to be Discontinued Epigenomic Controllers. For the avoidance of doubt, at any time before designation of a Development Candidate as the IND-Enabling Candidate, the Parties may replace the Development Candidate with another Epigenomic Controller-LNP Candidate that uses the Program Epigenomic Controller and, upon such replacement, such Epigenomic Controller-LNP Candidate shall be the Development Candidate for all purposes hereunder. [***] shall have final decision making authority with respect to replacement of the Development Candidate under this Section 3.2.3.
Development Candidate Designation