Study Initiation definition
Examples of Study Initiation in a sentence
Sponsor reserves the right to immediately terminate this Agreement and to exclude Hospital and Investigator from further participation in the Clinical Study, if within three (3) months after the Study Initiation Visit no patients are participating in the Clinical Study.
The payment schedule and price of this study are as follows: · 15% Due upon Authorization* · 12.5% Due upon Study Initiation (Day 1) · 12.5% Due Interim – Month 2 · 12.5% Due Interim – Month 3 · 12.5% Due Interim – Month 4 · 12.5% Due Interim – Month 5 · 12.5% Due Interim – Month 6 · 5% Due upon Submission of Draft Report · 5% Due upon Submission of Final Report** *Invoice(s) will be sent no more than 60 days prior to scheduled study start.
If Study Initiation of the Phase II Clinical Trial in the PKD Field referenced in Section 7.1 does not occur by December 31, 2012, then (i) Licensee shall pay Symphony a non-refundable fee equal to *** and (ii) Symphony shall have the right to terminate this Agreement with respect to the Non-Oncology Field, effective immediately.
Institution and Investigator agree that, if at any time from the beginning of the Study (Study Initiation Visit), until one (1) year from the end of the Study (Study Close-out Visit), Institution and/or Investigator should become aware of any changes in the financial disclosure any Subinvestigator participating in the Study, Institution and/or Investigator will immediately notify MedImmune and cooperate with MedImmune in providing a revised financial disclosure statement reflecting all required changes.
For clarity, there shall not be any payment for any of the above milestone events prior to Phase III Study Initiation where the Licensed Product is not covered by a Valid Composition of Matter Claim.
Any delay of the Phase 1 Study Initiation by more than [***] (if not mutually agreed by the Parties) shall only occur if required by Applicable Law or the mandatory instruction of a Regulatory Authority made in accordance with Applicable Law.
Bluebird will provide written notice to Celgene of the enrollment of the first patient in each initial Clinical Study for each Product Candidate (the “Clinical Study Initiation Notice”).
For clarity, no additional payment shall be due pursuant to this Section 7.2.2.2 in the event that Study Initiation of the Phase II Clinical Trial in the PKD Field occurs prior to July 1, 2013.
If Study Initiation of the Phase III Clinical Trial in the Oncology Field referenced in Section 7.1 does not occur by December 31, 2011, then (i) Licensee shall pay Symphony a non-refundable fee equal to *** less any amounts actually paid by Licensee to Symphony pursuant to Section 4.2.1 and Section 4.2.2 and (ii) Symphony shall have the right to terminate this Agreement with respect to the Oncology Field, effective immediately.
In addition, Licensee shall promptly, but in no event later than *** days thereafter, provide Symphony with written notice of (i) Study Initiation of any Phase III Clinical Trial, or (ii) Licensee entering into a written agreement with any non-Affiliate Third Party, in each case that obligates Licensee to pay the Development Fee pursuant to the immediately preceding sentence.