“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.

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;

“Clinical Trials” means a clinical trial in human subjects that has been approved by a Regulatory Authority and an institutional review board or ethics committee, and is 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.

“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.

unless expressly prohibited by any Regulatory Authority, transfer control to ​ of all Clinical Studies being Conducted by [[Organization A:Organization]] as of the effective date of termination and continue to Conduct such Clinical Studies, […​…], for up to […​…] to enable such transfer to be completed without interruption of any such Clinical Study; provided, that # ​ shall not have any obligation to continue any Clinical Study unless required by Applicable Law, in which case ​, if it wishes to terminate such Clinical Study, shall continue such Clinical Study […​…] until such time that Applicable Law allows such trial to be terminated (with ​ taking all reasonable steps to promptly terminate such Clinical Study and minimize all costs and expenses), and # with respect to each Clinical Study for which such transfer is expressly prohibited by the applicable Regulatory Authority, if any, [[Organization A:Organization]] shall continue to Conduct such Clinical Study to completion, […​…];

“Development Costs” means any and all internal and out-of-pocket costs and expenses incurred by or on behalf of Zai Lab, its Affiliates licensees, and/or sublicensees in connection with the Development of the Products in the Territory pursuant to this Agreement. For clarity, Development Costs shall include, without limitation, the costs of manufacturing, any pre-clinical studies, Phase I Studies, Phase II Studies, Phase III Studies, Phase IV Studies, and any post-approval studies that are required by Regulatory Authorities as a condition to receiving Regulatory Approval for the Product.

“GMP Run” means a production run manufactured according to cGMP guidelines to produce Product that will be tested and released for clinical studies and/or commercial supplies.

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

Transferred Clinical Trials. Without limiting its obligations under Section 3.2.1, Licensee shall be solely responsible, at its own cost and expense, for conducting and completing all Transferred Clinical Trials and any other trial to satisfy post-marketing commitments necessary or desirable to obtain or maintain Regulatory Approval of and enable and support the Manufacture and Commercialization of Licensed Products in the Territory. Axsome and Licensee shall undertake all actions reasonably necessary to transfer Axsome’s responsibilities and obligations under the Transferred Clinical Trials to Licensee and to assign to Licensee those clinical trial agreements listed in [Schedule 3.3.1], which are in existence as of the Effective Date and under which such Transferred Clinical Trials are being conducted.

Early Clinical Development. Subject to the terms and conditions of this Agreement, on a Development Candidate-by-Development Candidate basis, effective as of the date on which the Collaboration Antigen of such Development Candidate becomes a “Collaboration Antigen” under this Agreement, during the Early Clinical Development Term, SGI hereby grants to Unum an exclusive, sublicensable (solely as permitted in accordance with Section 10.4), royalty-free, fully-paid, worldwide license, under the SGI Background Technology and SGI Program IP, to clinically Develop such Development Candidate (and Manufacture same but only for such purpose and only as provided in this Agreement), all in accordance with the Early Clinical Development Plan, save that SGI will retain such rights as are necessary to perform any activities that the Parties may agree that SGI will perform under this Agreement.