Clinical Milestone means the date occurring ninety (90) days following the delivery by Xxxx 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 Xxxx relating to the one year follow-up of at least 200 implanted resorbable drug coated stents of Xxxx 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 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).
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.
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 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.
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.
To the extent not paid pursuant to Section 3.2 of the Option Agreement, a one-time payment of the Clinical Milestone Payment payable in accordance with Section 1.17.
ADDITIONAL PAYMENTS 8.1 Clinical Milestone Payment: Licensee shall pay to The Regents [***] within thirty (30) days of the commencement of a clinical [***].
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 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 means the completion of a human clinical trial of the Product designed to support Regulatory Approval.
Clinical Milestone shall have the meaning ascribed thereto in Section 3.1.
Clinical Milestone means the satisfaction of each of the following events: (a) no default or Event of Default shall have occurred and be continuing and (b) Borrower shall have announced and delivered supporting documentation satisfactory to Agent (as determined by Agent in its reasonable discretion) that Borrower has achieved a protocol specified primary endpoint for at least one dose from the Phase 3 MAESTRO-XXXX (NCT03900429) trial, which taken together with the safety data from the Phase 3 MAESTRO-NAFLD-1 (NCT04197479) trial and the overall safety profile from both such trials, support the filing of a New Drug Application as the next immediate step in development (as determined by Xxxxxxxx’s executive team and Board, subject to the Lenders’ reasonable verification).
Clinical Milestone means satisfaction of each of the following events: (a) no default or Event of Default shall have occurred and be continuing; and (b) any Loan Party or other third party collaborator with such collaborator and collaboration agreement being acceptable to Agent in its sole but reasonable discretion (such determination not to be unreasonably withheld or delayed) has announced that the Phase 3 EMPOWUR study of Vibegron for the treatment of overactive bladder (wet or dry) in women and men as described in clinical study protocol RVT- 901-3003 has met both protocol-specified co- US-DOCS\105484033.25 primary efficacy endpoints with statistical significance and with Vibegron demonstrating an acceptable safety profile such that the data supports the filing of a New Drug Application with the FDA and such Loan Party’s executive officers have approved proceeding towards the filing of such New Drug Application, subject to reasonable verification by Agent (including supporting documentation reasonably requested by Agent).
Clinical Milestone means, as reasonably determined by Agent, and in consultation with Xxxxxxxx, Borrower has generated clinical data on primary and secondary endpoints from the clinical evaluation of EG-70 in a Phase 1 clinical trial in patients with BCG-nonresponsive NMIBC which, taken as whole, provides the basis for the progression of the clinical evaluation in a Phase 2 clinical trial as the next step in clinical development.