Clinical Milestone definition
Clinical Milestone means the date occurring ninety (90) days following the delivery by ▇▇▇▇ to BSC of each of (i) all material information (including, but not limited to, all case report forms and all data concerning imaging, death, MI, ST and TLR) available to ▇▇▇▇ relating to the one year follow-up of at least 200 implanted resorbable drug coated stents of ▇▇▇▇ from a human clinical trial conducted in accordance with applicable laws and regulations (the “Implanted Stents”), (ii) all material information (including, but not limited to, core lab acute gain, late loss, and binary angiographic restenosis) relating to the 8-9 month angiographic follow-up of at least 100 of such Implanted Stents, and (iii) all material information relating to the 8-9 month IVUS of at least 40 of such Implanted Stents.
Clinical Milestone means (a) no Event of Default shall have occurred and be continuing and (b) Borrower shall have announced and delivered supporting documentation satisfactory to Agent that (i) the Phase 2 study evaluating ELX-02 as single agent in the treatment of patients with cystic fibrosis with at least one G542X allele (NCT04135495) has met its primary endpoint and has shown favorable trends across its secondary endpoints and (ii) the combination of ELX-02 and ivacaftor to treat the same patients in the expansion arm in Israel has shown a favorable safety profile and efficacy trends and that such results, when taken together, will support the initiation of a registration directed trial as the next immediate step in development, as determined by the Borrower and the board of directors of the Borrower, and accepted at Agent’s discretion.
Clinical Milestone means satisfaction of each of the following events: (a) no Event of Default shall have occurred and be continuing; and (b) any Loan Party has announced that the Phase 3 MINDSET study of intepirdine for the treatment of Alzheimer’s disease as described in clinical study protocol RVT-101-3001 has met both co-primary endpoints with intepirdine demonstrating an acceptable safety profile such that the data supports the filing of a New Drug Application with the Food and Drug Administration, subject to verification by Agent in its reasonable discretion (including supporting documentation requested by Agent).
Examples of Clinical Milestone in a sentence
For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Clinical Milestone Event).
Voyager shall review the Clinical Trial Plan at least on a quarterly basis and may in its reasonable discretion change such plan and any Clinical Milestone Target Date therein at any time.
Voyager promptly shall notify SBS in writing in the event of any material change to the Clinical Trial Plan or in the event that any Clinical Milestone Target Date is delayed by one calendar quarter or more.
All Milestone Events prior to the second Clinical Milestone Event may only be referenced in public announcements in general terms and without specificity as to the particular milestone.
The Company’s board of directors, at a meeting duly called and held, adopted resolutions approving the transactions contemplated hereby, including the issuance of the PKU Technology Access Fee Shares, and the Clinical Milestone Shares issuable upon occurrence of the various Milestone Events in a manner consistent with and that meets the requirements of Nevada Corporate Code contained in Chapter 78 of the Nevada Revised Statutes.
More Definitions of Clinical Milestone
Clinical Milestone means the date occurring ninety (90) days following the delivery by Reva to BSC of each of (i) all material information (including, but not limited to, all case report forms and all data concerning imaging, death, MI, ST and TLR) available to Reva relating to the one year follow-up of at least 200 implanted resorbable drug coated stents of Reva from a human clinical trial conducted in accordance with applicable laws and regulations (the “Implanted Stents”), (ii) all material information (including, but not limited to, core lab acute gain, late loss, and binary angiographic restenosis) relating to the 8-9 month angiographic follow-up of at least 100 of such Implanted Stents, and (iii) all material information relating to the 8- 9 month IVUS of at least 40 of such Implanted Stents.
Clinical Milestone is hereby amended by replacing “Food and Drug Administration” with “FDA” therein. The definition of “Permitted Convertible Debt Financing” is hereby amended by replacing “Two Hundred Million Dollars ($200,000,000.00)” with “Three Hundred Million Dollars ($300,000,000.00)” therein.
Clinical Milestone means Borrower shall have announced that Borrower’s Phase 3 PHALCON-EE trial, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ identifier NCT04124926, has achieved its protocol-specified primary efficacy endpoints with acceptable safety data, such that the results support the submission of a New Drug Application or supplemental New Drug Application without the need to conduct another Phase 3 study (as determined by Borrower’s executive team and Board, subject to Lenders’ reasonable verification). For the avoidance of doubt, statistical superiority with respect to any secondary endpoints does not need to be demonstrated in Borrower’s PHALCON-EE trial for purposes of the this milestone.
Clinical Milestone means satisfaction of each of the following events: (a) no Event of Default shall have occurred and be continuing and (b) Parent has announced that one of the following events has occurred: (i) the two Phase 3 studies of relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids as described in clinical study protocols MVT-601-3001 and MVT-601-3002 have each met the primary efficacy endpoint with relugolix demonstrating an acceptable safety profile such that the data support the submission of a New Drug Application to the FDA for the treatment of heavy menstrual bleeding associated with uterine fibroids, (ii) the two Phase 3 studies of relugolix for the treatment of endometriosis-associated pain as described in clinical study protocols MVT-601-3101 and MVT-601-3102 have each met both the co-primary efficacy endpoints with relugolix demonstrating an acceptable safety profile such that the data support the submission of a New Drug Application to the FDA for the treatment of endometriosis-associated pain, or (iii) the Phase 3 study of relugolix for the treatment of advanced prostate cancer as described in clinical study protocol MVT-601-3201 has met the primary efficacy endpoint with relugolix demonstrating an acceptable safety profile such that the data support the submission of a New Drug Application to the FDA for the treatment of advanced prostate cancer; with each subject to confirmation by Agent in its reasonable discretion (including supporting documentation requested by Agent).
Clinical Milestone means (a) Borrower has satisfied the Performance Conditions relating to (***) and (b) Borrower has provided evidence to the Agent in form and substance satisfactory to Agent (which, for the avoidance of doubt, may be satisfied by the issuance of a public filing and press release from Borrower of the following) that (***).
Clinical Milestone means satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred or be continuing; and (b) delivery by the Borrower of written notice to Agent that Borrower has achieved the protocol specified primary endpoints from the clinical evaluation of EG-70 in the Phase 2 LEGEND clinical study (NCT04752722) in patients with BCG-nonresponsive NMIBC, which taken together with other secondary endpoints and overall safety profile, support the filing of a Biologics License Application with the FDA as the next immediate step in development, subject to the Agent’s reasonable verification.
Clinical Milestone will have the meaning ascribed to it in Section 6.1.1.
10. “Clinical Milestone Payment(s)” will have the meaning ascribed to it in Section 6.1.1.