Clinicals Sample Clauses

Clinicals. The weekly teaching workload is 21.0 regularly scheduled class contact hours where the principal instructional delivery mode is through the clinical method. Clinical shall be defined as regularly scheduled nursing instruction in an external agency in which the student applies concepts and techniques under the conditions of the external agency, and in which the instructor assumes primary responsibility for instruction and evaluation of a student. Supervision of students is the prime responsibility of the instructor, but may be shared with personnel from the external agency. The annual workload will consist of 683 hours of clinical class contact hours.
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Clinicals. Somnus shall be responsible for all clinical study --------- design, investigator selection, data analysis in connection with clinical trials of the Products. Medtronic shall assist Somnus in such clinical study activities such as investigator selection, and such other clinical matters as the parties may agree. The cost of clinical studies for the evaluation of the uvula, palate, turbinate, and tongue procedures will be borne by Somnus, [ * ] Payments will be made to clinical investigators only upon receipt of completed and acceptable patient data sets. Somnus and Medtronic will work together to select such centers based on their ability to provide quality clinical data and promote market development. Without limitation of the foregoing, Somnus will provide the centers with the clinical protocol, assist with ethics approval, provide all required technical training and support, and provide data analysis. Somnus shall provide training at up to three (3) training sessions in the Territory designed to instruct multiple investigators. Medtronic shall organize those sessions in coordination with Somnus. Somnus shall pay the local costs of running such training, such as transportation, local living expenses, cost of putting on such training and any directly related consulting costs incurred in connection therewith. Medtronic shall devote clinical management personnel resources reasonably necessary to perform Medtronic's obligations under this Agreement. Medtronic shall be responsible for site monitoring and on-site support for all clinical investigations.
Sample 1
Clinicals. Medtronic shall be responsible for all clinical study design, investigator selection, and data analysis in connection with clinical trials of the Developed Products (with the exception of TS Surgical Film). MacroPore shall give Medtronic such assistance in connection with such clinical studies as Medtronic may reasonably request.
Sample 1
Clinicals. MacroPore shall be responsible for any and all clinical study design, investigator selection, data analysis in connection with clinical trials of the TS Surgical Film. Medtronic shall assist MacroPore in such clinical study activities such as investigator selection, and such other clinical matters as the parties may agree.
Sample 1
Clinicals. Clinicals represents and warrants that: (i) it has full power to enter into the Agreement; and (ii) it has obtained all necessary corporate approvals to enter and execute into this Agreement; (iii) the Materials provided by Clinicals will be suitable for use by Medarex in connection with the activities set forth on Exhibit A.
Sample 1
Clinicals. Clinicals shall indemnify, defend and hold harmless Medarex, its directors, officers, employees, agents, successors and assigns (each an "Indemnitee") from and against all liabilities, expenses or costs (including reasonable attorneys' fees) ("Liability") arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a third party alleging physical injury or death or otherwise resulting from (i) the clinical testing of the Product by or on behalf of Clinicals; (ii) the safety of the Product distributed by or on behalf of Clinicals; (iii) the promotion, distribution, sale, handling, possession, or use of the Product by or on behalf of Clinicals following its or their acceptance thereof in accordance with Section 1.4 above; (iv) any negligent or intentionally wrongful acts or omissions of Clinicals; (v) any claim that the Product infringes any third party's intellectual property rights; and (vi) any breach by Clinicals of its representations and warranties under Section 5.2 above, in each case subject to the requirements set forth in Section 6.3 below.
Sample 1
Clinicals. Cordis will conduct all Clinicals in a competent manner in accordance with applicable legal requirements. Cordis will be responsible for determining what Clinicals will be conducted in what countries after consultation with the Steering Committee; provided, however, that Cordis will conduct all Clinicals required to obtain regulatory approval to commence commercial marketing and sale of X-Ray Systems in the United States, the European Union and Japan. Once Cordis determines that clinical testing is desirable in a particular country (other than as necessary for regulatory approval in the U.S., the European Union or Japan) to obtain approval to commence commercial marketing of X-Ray Systems, Cordis will conduct Clinicals (the manner, timing and conduct of such Clinicals, the extent and duration thereof and the completion of which shall be determined by Cordis in its reasonable discretion ) and such other testing as Xxxxxx xxxxx appropriate or desirable in connection with the X-Ray System. PEC will cooperate with Cordis in conducting such Clinicals and take such reasonable actions as Cordis shall reasonably request in connection therewith. PEC will cooperate by providing at its expense one Control Device and thirty (30) X-Ray Catheters to Cordis for each clinical trial required to obtain initial FDA approval for the X-Ray System. Such components will be returned to PEC after each clinical trial is completed. If Cordis requires additional X-Ray Catheters, it shall purchase such X-Ray Catheters from PEC at PEC's then current cost. Cordis will retain ownership of all data generated from the Clinicals and all results obtained from such data. Cordis will share the results of such Clinicals with PEC. PEC will have the right to use data generated during animal trials outside the Field. This information is considered confidential and shall be treated as such in accordance with Section XII.
Sample 1
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Related to Clinicals

  • Clinical Studies The 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 and complete 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 the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification 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.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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