“Clinical Trials” means a clinical trial in human subjects designed to measure the safety and/or efficacy of a Licensed Product. Clinical Trials shall include Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials and any pre-clinical or post-Regulatory Approval studies undertaken in relation to any Licensed Product.

. “Clinical Studies” means all studies, tests and preclinical and clinical trials conducted by or on behalf of Seller were and, if still pending, are, and in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Laws and Authorizations.

“Development” or “Develop” shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.

In addition to the rights set for in Section 13.2.2, solely in the case of a Change in Control of ​ that occurs after ​ having completed all Initial Development Activities but before ​ having completed any Clinical Studies as referred to in Sections 3.1.4 or 3.1.7, respectively, [[Organization A:Organization]] shall have the right, in its sole discretion, to either require the Change in Control party to # promptly transfer such ongoing Clinical Studies to [[Organization A:Organization]], or # promptly wind down and terminate such ongoing Clinical Studies in a manner that is permitted under Applicable Law.

at Neuren’s expense, arrange for the transfer of sponsorship of any clinical or non-clinical studies of any Product of which ACADIA or its Affiliate is the sponsor that are in progress to enable Neuren to continue such studies if it elects to do so by written notice to ACADIA provided on or before the effective date of termination;

“Development Plan” means a development plan (other than the Initial Development Plan and Budget) setting forth in reasonable detail specific Clinical Studies and other Development activities (other than the Initial Development Activities) to be performed with respect to the Licensed Compound or a Licensed Product, which plan shall set forth Clinical Studies and Development activities subsequent to those of the Initial Development Plan and Budget.

While at this time we are making no such claims, we believe it is likely that our formulations are producing similar results. We believe it is possible at a future date to conduct clinical studies to confirm such possible results.

“Engineering Run” means a fermentation run, at the same scale as the intended GMP batch, conducted for the purpose of testing a manufacturing process, identifying and resolving any potential issues with equipment or cGMP documentation prior to clinical GMP manufacturing, and supplying material for non-clinical use and/or stability studies. An Engineering Run is not for the purpose of manufacturing Product in conformance with cGMP.

Reporting. Spero shall provide to Northern a written report for each calendar quarter, which shall adequately describe the status of the development and commercialization of the Licensed Compounds and Licensed Products (including for the avoidance of doubt any Combination Product), including at a minimum: results and data of any clinical or non-clinical studies and ​. All such reports and their contents shall constitute Confidential Information of Spero.

assign (or cause its Affiliates to assign) to ​ all agreements with any Third Party with respect to the conduct of pre-clinical Development activities, Manufacturing or Clinical Studies for the Licensed Products, including agreements with contract research organizations, contract manufacturing organizations, clinical sites, and investigators, unless, with respect to any such agreement, such agreement # expressly prohibits such assignment, in which case [[Organization A:Organization]] shall cooperate with ​ in reasonable respects to secure the consent of the applicable Third Party to such assignment, or # covers Clinical Studies for Combination Products in which any active ingredient that is not a Licensed Compound is covered by Patents Controlled by [[Organization A:Organization]] or any of its Affiliates or covers products covered by Patents Controlled by [[Organization A:Organization]] or any of its Affiliates in addition to the Licensed Products, in which case [[Organization A:Organization]] shall, […​…], cooperate with ​ in all reasonable respects to facilitate the execution of a new agreement between ​ and the applicable Third Party; and