Clinicals Sample Clauses
The "Clinicals" clause defines the terms and conditions under which clinical trials or studies are conducted as part of an agreement. It typically outlines the responsibilities of each party regarding the design, conduct, monitoring, and reporting of clinical activities, and may specify requirements for regulatory compliance, data sharing, and subject safety. This clause ensures that all clinical work is performed according to agreed standards and legal requirements, thereby protecting the interests of both parties and safeguarding the integrity of the clinical data.
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.
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 ▇▇▇▇▇▇ ▇▇▇▇▇ 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.
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.
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.
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.
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.
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.
