Pre-Clinical Studies shall mean in vitro and in vivo studies of a Collaboration Compound, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Collaboration Compound and whether the Collaboration Compound has a desired effect.
Notwithstanding anything express or implied in this Agreement (including, without limitation, this Section 6.2) to the contrary, Ipsen shall continue until completion certain [ ]* that are identified on Appendix C and are ongoing as of the Effective Date under its sole responsibility and decision-making authority (collectively, the Ipsen Ongoing Pre-Clinical Studies).
Regulus shall [...***...] use its Diligent Efforts to manufacture pre-clinical supplies and clinical supplies of Collaboration Compounds, including all bulk drug substance, for all Pre-Clinical Studies and Clinical Studies, including process development and scale-up, conducted by Regulus under such Program during the Program Term for such Program.
If Alizyme fails to comply with its obligations under the Development Plan as provided in Section 3.8.1(b) with respect to its proper and timely conduct of the Pre-Clinical Studies, Prometheus shall have the right, in addition to any other rights or remedies under this Agreement or applicable Law, to conduct and control such Pre-Clinical Studies as specified in the Development Plan and Alizyme shall promptly reimburse Prometheus for Prometheus' Fully-Burdened Costs incurred in connection therewith.
Quark shall update the JRC from time to time regarding the progress of its Non-Ophthalmic Pre-Clinical Studies, and shall provide the JRC with the data and other results of such studies as soon as practicable after such studies are completed.
Pre-Clinical Studies and Pharmacokinetic Studies.........................