Clinical Development Candidate definition
Examples of Clinical Development Candidate in a sentence
If no Development Additional Work is agreed or no Clinical Development Candidate is nominated by the JSC after Completion of such Development Additional Work, then GSK shall terminate the applicable Collaboration Program in accordance with Section 13.3 and Section 13.6 shall apply.
The Parties, either separately or jointly, may submit written proposals for Clinical Development Plans for any Clinical Development Candidate (“Proposed Clinical Plans”) to the JSC for review (which review shall take place at the first JSC meeting following submission of a Proposed Clinical Plan to the JSC) and recommendation to the Parties; provided that each Party may submit no more than one Proposed Clinical Plan per calendar quarter during the Term.
Angiotech shall have the primary responsibility for communicating with any regulatory authority regarding any IND application or other regulatory filing pertaining to a Clinical Development Candidate that has completed a Phase I Study, and regarding any Clinical Development Candidate or Cell Therapy Product that has been submitted for, or has obtained, Regulatory Approval.
In addition, Athersys shall teach and instruct personnel of Angiotech (or Angiotech’s designee) how to obtain appropriate raw materials and how to reproduce the production and manufacturing processes and techniques used by Athersys for production and manufacturing of the Clinical Development Candidate or Cell Therapy Product (as applicable).
In the event that Athersys is materially unable, at any time, to fulfill its obligation to supply Clinical Development Candidates or Cell Therapy Products in a timely manner, as required hereunder, for any reason (a “Supply Disruption”), Athersys shall promptly notify Angiotech of such Supply Disruption and the estimated extent of such Supply Disruption (including the anticipated delay time and the quantity of Clinical Development Candidate or Cell Therapy Product involved).
If no Clinical Development Candidate is nominated by the JSC after Completion of the Development Additional Work, then GSK shall terminate the applicable Collaboration Program in accordance with Section 13.3 and Section 13.6 shall apply.
Upon delivery of the Opt-Out Notice, the subject Clinical Development Candidate or Cell Therapy Product shall be deemed a “Rejected Product.” The Discontinuing Party shall be required to continue co-funding all of its activities under this Strategic Alliance Agreement during such six (6) month notice period (subject to the first sentence of this Section 6.1).
Upon the JSC’s determination that at least one Lead Candidate satisfies the applicable Clinical Development Candidate Criteria, such Lead Candidate shall be deemed the Clinical Development Candidate.
The Parties shall share equally all (a) income received from such Third Party(ies) and (b) Clinical Development Costs, Commercialization Costs and Manufacturing Costs (as applicable) associated with the wind-down of activities related to the applicable Clinical Development Candidate or Cell Therapy Product.
Athersys shall have the primary responsibility for communicating with any regulatory authority regarding any IND application or other regulatory filing pertaining to a Clinical Development Candidate that has not yet completed a Phase I Study.