Clinical Milestone definition
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 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 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 optical coherence tomography (OCT) of at least 40 of such Implanted Stents.”
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) Parent shall have stated in Parent’s public filings with the Securities and Exchange Commission and delivered supporting documentation satisfactory to Agent (as determined by Agent in its reasonable discretion) that it has achieved a protocol specified primary endpoint from the study entitled, Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer (CERPASS) (NCT04050436) which, taken together with other secondary endpoints, support the submission of a BLA Filing as the next immediate step in development (as determined by ▇▇▇▇▇▇▇▇’s executive team and Board of Directors and subject to Lender’s reasonable verification). “Closing Date” means the date of this Agreement. “Code” means the Internal Revenue Code of 1986, as amended. “Common Stock” means the common stock of Parent. “Company IP” means any and all of the following, as they exist in and throughout the United States of America: (a) Current Company IP; (b) improvements, continuations, continuations-in-part, divisions, provisionals or any substitute applications, any Patent issued with respect to any of the Current Company IP, any Patent right claiming the composition of matter of, or the method of making or using, the Products in the United States of America, any reissue, reexamination, renewal or Patent term extension or adjustment (including any supplementary protection certificate) of any such Patent, and any confirmation Patent or registration Patent or patent of addition based on any such Patent; (c) trade secrets or trade secret rights, including any rights to unpatented inventions, know-how, show-how, operating manuals, confidential or proprietary information, research in progress, algorithms, data, databases, data collections, designs, processes, procedures, methods, protocols, materials, formulae, drawings, schematics, blueprints, flow charts, models, strategies, prototypes, techniques, and the results of experimentation and testing, including samples, in each case, as specifically related to any research, development, manufacture, production, use, commercialization, marketing, importing,
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, after the Second Amendment Closing Date, but on or prior to March 31, 2027: (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 (including supporting documentation reasonably requested by Agent).
Clinical Milestone means, as reasonably determined by Agent, and in consultation with ▇▇▇▇▇▇▇▇, 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.
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 delivered evidence (subject to Agent’s reasonable verification) that ▇▇▇▇▇▇▇▇ has announced positive interim or final primary endpoint data from at least one of the ongoing Phase 3 pivotal studies of its drug candidates (i.e. STAR-221, STAR-121, PRISM-1 and/or PEAK-1), which taken together with an acceptable safety profile, support the filing of a Biologics License Application or a New Drug Application to the FDA as the immediate next step in development.