GLP Tox definition
Examples of GLP Tox in a sentence
The JDC shall strive by consensus to prepare a Phase I Plan for each Collaboration Target no later than thirty (30) days after the start of GLP Tox Studies for such Collaboration Target.
A joint research committee (the “JRC”) shall monitor the progress of the research program for Potential Licensed Compounds, and permit collaboration, wherever possible, during compound discovery through GLP Tox Completion or End of Phase 1, as applicable, for any given Potential Licensed Compound.
Subject to the terms and conditions of this Agreement, uniQure hereby grants to 4DMT, and 4DMT hereby accepts, during the Research Term and any applicable GLP Tox Candidate Review Period in effect as of the end of the Research Term, a non-exclusive, worldwide, royalty-free, non-sublicenseable license under the uniQure Intellectual Property, solely to the extent necessary to conduct activities assigned to 4DMT under the Research Plan.
Progress of up to […***…] Collaboration Compounds satisfying CCS Criteria through GLP Tox Studies for a Collaboration Target shall be at BPM’s sole expense.
For clarity, in the event that Roche does not exercise its Option at GLP Tox Completion, Pharmasset shall not be required to conduct further development of such Potential Licensed Compound.
In the event that Roche exercises its Option earlier than GLP Tox Completion, Pharmasset shall have no responsibility for any GLP Tox Completion activities that were not initiated prior to Roche’s exercise of its Option, and Roche shall assume such responsibility for the remaining GLP Tox Completion activities, to the extent that the JDMC determines that such activities are necessary for development of such Potential Licensed Compound.
For the purposes of this Section 4.3.7, “Significant Study” shall mean any GLP Tox Study or Clinical Study.
Notwithstanding the foregoing, uniQure shall be deemed to have accepted as a GLP Tox Compound any Research Compound that it advances into pre-clinical Development conducted under Good Laboratory Practices.
Additional Backup Compounds may be progressed through a GLP Tox Study at Roche’s sole discretion and expense (including any supply thereof) as part of the Research Plan and under the supervision of the JRC, provided that BPM will have the right to conduct (or have conducted) any such GLP Tox Study, and if BPM elects such right then Roche shall reimburse BPM for any personnel costs, Allocable Overhead or Out of Pocket Expenses incurred by BPM with respect thereto.
Notwithstanding the foregoing, the Candidate Success Criteria shall be deemed to have been met for any Research Compound that uniQure advances into GLP Tox Studies.