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.