BENCHMARKS AND PERFORMANCE Sample Clauses

BENCHMARKS AND PERFORMANCE. Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved.

BENCHMARKS AND PERFORMANCE. Licensee agrees to the following Benchmarks for its performance under this Agreement and, within [***] of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved.

BENCHMARKS AND PERFORMANCE. The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify the NIH that the Benchmark has been achieved.

BENCHMARKS AND PERFORMANCE. Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved. I. For the Stem cell mobilization therapeutic indication (pre-clinical and Phase I studies using IB-MECA have already been accomplished) 1. Initiate FDA Phase II/III clinical trials or foreign equivalent clinical trials by the end of the fourth quarter of 2003. 2. Submission of a New Drug Application (NDA) (or its equivalent) to the FDA (or its foreign equivalent) for a Licensed Product or Process by the end of the fourth quarter of 2004. II. For the Myeloprotection therapeutic indication (pre-clinical and Phase I studies using IB-MECA have already been accomplished): 1. Initiate FDA Phase II clinical trials or foreign equivalent clinical trials by the end of the fourth quarter of 2003. 2. Initiate FDA Phase III clinical trials or foreign equivalent clinical trials by the end of the fourth quarter of 2004. 3. Submission of a New Drug Application (NDA) (or its equivalent) to the FDA (or its foreign equivalent) for a Licensed Product or Process by the end of the second quarter of 2006. III. For the Anti-cancer therapeutic indication (pre-clinical and Phase I studies using IB-MECA have already been accomplished): 1. Initiate FDA Phase II clinical trials or foreign equivalent clinical trials by the end of the first quarter of 2003. 2. Initiate FDA Phase III clinical trials or foreign equivalent clinical trials by the end of the third quarter of 2004. 3. Submission of a New Drug Application (NDA) (or its equivalent) to the FDA (or its foreign equivalent) for a Licensed Product or Process by the end of the first quarter of 2006.

BENCHMARKS AND PERFORMANCE. Now therefore, PHS and Licensee, intending to be bound, hereby mutually agree to the following:

BENCHMARKS AND PERFORMANCE. Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved. For the Anti-cancer therapeutic indication (for C1-IB-MECA):

BENCHMARKS AND PERFORMANCE. The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify the NIAID that the Benchmark has been achieved. Benchmarks for elderly RSV vaccination indication

BENCHMARKS AND PERFORMANCE. The following Paragraph 6.13 shall be added to the Agreement:

BENCHMARKS AND PERFORMANCE. Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been achieved. I. Initiate Preclinical Development Plan for a Licensed Product within three (3) months of the effective date of this Agreement. II. Submit an IND Filing on or before December 31, 2014. III. Initiate first Phase I clinical trial or foreign equivalent for Licensed Product by Fourth Quarter 2015. IV. Initiate first Phase II clinical trial or foreign equivalent for Licensed Product by Fourth Quarter 2016. V. Initiate first Phase III clinical trial or foreign equivalent for Licensed Product by Fourth Quarter 2017. VI. File first U.S. New Drug Application (NDA) directed to a Licensed Product by Fourth Quarter 2019. VII. File first submission to a foreign regulatory authority for market approval of a Licensed Product by Fourth Quarter 2019. VIII. Gain first regulatory market approval from a regulatory authority for a Licensed Product by First Quarter 2021. IX. Complete First Commercial Sale in the United States by Fourth Quarter 2022. X. Complete First Commercial Sale in Australia by Fourth Quarter 2023. XI. Complete First Commercial Sale in Canada by Fourth Quarter 2022. XII. Complete First Commercial Sale in Europe by Fourth Quarter 2023. XIII. Complete First Commercial Sale in Japan by Fourth Quarter 2024.

BENCHMARKS AND PERFORMANCE. Within sixty (60) days of the execution of this Ninth Amendment, the Licensee shall pay the NIH an amendment issue royalty in the sum of Five Thousand US Dollars ($5,000), and payment options may be found in Attachment 1.