Example ContractsClausesClinical Studies
Clinical Studies
Clinical Studies contract clause examples

Clinical Studies. Where any clinical study of any Licensed Product is ongoing upon termination, each Party shall continue, at its cost, the clinical study for which it, its Affiliate, (sub)contractor or sublicensee is the regulatory sponsor, solely as deemed necessary by such Party based on reasonable medical judgment to protect the safety, health or welfare of subjects participating in the relevant clinical study, until such point as the study is completed or, if earlier, such Party determines that it is ethical to terminate such study or otherwise cease supporting it.

Clinical Studies. The preclinical studies and tests and clinical trials described in the Registration Statement and the Prospectus were, and, if still pending, are being conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of such studies, tests and trials, and the results thereof, contained in the Registration Statement and the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Registration Statement, the Prospectus or any SEC Report, the results of which reasonably call into question the results of the tests, studies and trials described in the Registration Statement and the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority or any institutional review board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials.

Clinical Studies. All clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company, except where such noncompliance would not reasonably be expected to have a Material Adverse Effect; the descriptions of the results of such clinical trials contained in the Registration Statement and the Prospectus are accurate in all material respects, and the Company has no knowledge of any other clinical trials, the results of which reasonably call into question the clinical trial results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA or any other domestic or foreign governmental agency requiring the termination or suspension of any clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company as described in the Prospectus (the “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 and scientific standards and all applicable Health Care Laws and Authorizations; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company has no knowledge of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any Clinical Studies, except where any such termination, suspension or modification would not reasonably be expected to result in a Material Adverse Effect.

Clinical Studies. XPH will be responsible for, and conduct and administer at its sole cost and expense, all the studies required for Regulatory Approval in each of countries within the Territory. Specifically, XPH will:

Ongoing Clinical Studies. ​ shall remain responsible for and shall complete ​ all ongoing Clinical Studies as of the Effective Date that are listed in EXHIBIT 3, including all analysis and reports that are reasonably necessary to obtain, extend or update the Marketing Authorization of the Product with the EMA, and shall remain responsible for contracting with and managing any Third Party that may be involved with such Clinical Studies (each, an “Ongoing Clinical Study”).

Prior to initiating a new Clinical Study (including, for the purposes of this Section, any marketing studies, Post-Approval Commitment Studies, and Phase IV Studies for the Product) that is not an Ongoing Atea Study and is not an ongoing Unilateral Study (as defined below) or included in the then-current Global Development Plan, the Party that desires to conduct such Clinical Study (the “Proposing Party”) shall propose such Clinical Study to the JOC, which proposal shall include a synopsis of the protocol for such Clinical Study and an estimated budget for such Clinical Study. If the JOC agrees that the Parties should conduct such Clinical Study, then the Parties shall amend the Global Development Plan to include such Clinical Study. If the JSC does not agree that the Parties should conduct such Clinical Study, then the Proposing Party shall have the right, but not the obligation, to conduct such Clinical Study at its sole expense (each such Clinical Study, a “Unilateral Study”), provided that # ​, and # ​. For clarity, neither Party shall have the obligation to conduct or, except as may be required by Applicable Law or ethical requirements, complete any Unilateral Study.

Transfer of Clinical Studies. At aTyr’s written request if made by the effective date of termination by Kyorin pursuant to Section 13.2, Kyorin will use reasonable efforts to transfer to aTyr or its designated Third Party then on-going associated Clinical Studies at Kyorin’s costs and expenses. Kyorin will pay for, # subject to [Section 13.5.13], all reasonable Development Costs for the Licensed Products to be incurred by Kyorin in connection with the then on-going associated Clinical Studies until the transfer of the same to aTyr or its designee as set forth in this Section 13.5.2, or # the reasonable costs and expenses to wind-down those then on-going associated Clinical Studies that aTyr does not request for the transfer under this Section 13.5.2.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company ("Company Studies") were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls

Clinical Studies. Except as disclosed in the Registration Statement or the Prospectus, all animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from any domestic or foreign governmental agency requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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