Clinical Studies. All Clinical Studies were and, if still pending, are 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. [Schedule 4.7] sets forth a detailed description of the Clinical Studies conducted by Seller prior to the execution hereof. The descriptions of the results of such studies, tests and trials contained in [Schedule 4.7] are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; Seller is not aware of any studies, tests or trials the results of which call into question the Clinical Studies set forth in [Schedule 4.7] when viewed in the context in which such results are described and the clinical state of development; and Seller has not received any notices or correspondence from any Regulatory Agency or any other governmental authority requiring the termination, suspension or material modification of any Clinical Studies conducted by or on behalf of Seller.

[…​…]. The Parties agree and acknowledge the final Clinical Studies and the final design of such Clinical Studies shall ensure compliance with the minimum requirements set forth herein; provided, however, the final Clinical Studies and the final design of any Clinical Study conducted hereunder may be modified to incorporate, as necessary, results and data arising from pre-clinical studies, new scientific findings in the RA field, information/ recommendations gathered from discussions with the applicable Regulatory Authorities. Any such modifications would be subject to approval by the JDC.

[…​…]. The Parties agree and acknowledge the final Clinical Studies and the final design of such Clinical Studies shall ensure compliance with the minimum requirements set forth herein; provided, however, the final Clinical Studies and the final design of any Clinical Study conducted hereunder may be modified to incorporate, as necessary, results and data arising from pre-clinical studies, new scientific findings in the SLE field, information/ recommendations gathered from discussions with the applicable Regulatory Authorities. Any such modifications to the final design would be subject to approval by the JDC.

In such countries where ​ is performing Clinical Studies as part of the Initial Development Activities, Clinical Study Insurance with a minimum limit as required by law in the country or countries where such Clinical Studies are being performed.

oversee the conduct of all nonclinical studies and Clinical Trials included under each Research Plan, Early Clinical Development Plan and Late Clinical Development Plan, including Required Phase 4 Clinical Trials;

“Clinical Data” means all Information with respect to any Licensed Compound or Licensed Product made, collected, or otherwise generated under or in connection with Clinical Studies or Phase 4 Studies, including any data (including raw data), reports, and results with respect thereto.

good laboratory and clinical practice and Applicable Law. ​ and its Affiliates have employed (and, with respect to such tests and studies that ​ will perform, will employ) Persons with appropriate education, knowledge and experience to Conduct and to oversee the conduct of the pre-clinical and Clinical Studies with respect to the Licensed Compounds and Licensed Products.

ACADIA will be responsible for all costs associated with any clinical and non‑clinical development of any Compound or Product in the Territory following submission of any initial NDA in the United States, including any Phase III Clinical Studies and post-marketing studies that are required by the FDA as a condition of granting the FDA Approval or that are otherwise required by ACADIA. ACADIA will be responsible for conducting, at its own cost, any additional studies required

decide the appropriate roles and responsibilities for Neuren and ACADIA to develop such Compound for Fragile X Syndrome, including both clinical and non-clinical studies.

“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.

“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.

On a Development Candidate-by-Development Candidate basis, each Party will share with the other Party all safety and efficacy data generated with respect to such Development Candidate in all Clinical Trial(s) after the Qualifying Phase 1 Clinical Trial for such Development Candidate, and all correspondence to and from any Regulatory Authority regarding such Development Candidate and, upon either Party’s written request, such other relevant information reasonably requested by such Party regarding the Development Candidate in the other Party’s possession (but subject to Third Party confidentiality obligations) (collectively, “Late Clinical Development Trial Data”), following such Party’s receipt of same. Each Party will in good faith seek to obtain such information and make it available to the other Party.