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.

. “Proprietary Information” means any and all owned knowledge or data of the Seller, whether registered or not, including but not limited to, the Intellectual Property, Goodwill, Clinical Studies and Licenses.

“Development” or “Develop” - all preclinical development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, manufacturing clinical supplies, regulatory affairs, statistical analysis and report writing. When used as a verb, “Develop” shall mean to engage in Development.

“Technology” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, filings and correspondence (including DMFs), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable.

The S Edition is similar in the classic edition with the addition of natural ingredients that have been clinically tested to provide the known affect. The Company has completed no studies which demonstrate the effects of its product, but relies on the clinical studies of the ingredients that create energy, reduce stress, suppress appetites, speeds up metabolism, skin health, and improves sleep.

“Phase IV Study” means a clinical study or data collection effort for a Product that is initiated in one or more countries after the receipt of Regulatory Approval in such country(ies) and is principally intended to support the Commercialization of such Product in such country/countries and not to support or maintain the same or any additional Regulatory Approvals or otherwise obtain any labeling change. Phase IV Studies shall include, without limitation, clinical experience trials, but shall exclude post-approval studies that are required by a Regulatory Authority as a condition to receiving Regulatory Approval.

“Phase 0” means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing very early on whether the agent behaves in human subjects as was anticipated from pre-clinical studies.

“IND” means # an investigational new drug application filed with the FDA for authorization to commence clinical studies or any corresponding foreign application in the Territory and # all supplements and amendments that may be filed with respect to the foregoing.

inhibitors,” said Steve Paul, M.D., president of research & development and chief scientific officer. “Our lead candidate in the ​ program, GFB-887, has already demonstrated a compelling safety profile in non-clinical and clinical studies. We are fortunate to have found as advanced a clinical stage drug candidate directed against these important CNS targets and we will now study GFB-887 in various mood and anxiety disorders where there remains a significant unmet medical need for mechanistically novel medicines.”

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.

“Information” means information, results and data of any type whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.