Pivotal Study Sample Clauses

Pivotal Study. Entasis shall use Commercially Reasonable Efforts (either itself or through a Third Party contract research organization), at its expense, to conduct those activities associated with the global pivotal Phase III Clinical Trial for the Lead Product, as allocated to Entasis under and described in the Initial Development Plan (the “Pivotal Study”). The Initial Development Plan shall specify the responsible Party or contract research organization for all such activities. Pursuant to Section 5.6, Zai shall use Commercially Reasonable Efforts to conduct those activities for the Pivotal Study that take place in the Territory in accordance with the Development Plan. Zai shall be responsible for (i) [*] of Patient-Related Costs in the PRC for the Pivotal Study and (ii) [*] of Out-of-Pocket Costs incurred in connection with the Pivotal Study.
Sample 1Sample 2
Pivotal Study. 8 Section 1.57 Product.............................................................. 8 Section 1.58 Product.............................................................. 8 Section 1.59 Product Development Program.......................................... 8 Section 1.60 Product Development Term............................................. 8 Section 1.61 Regulatory Approval.................................................. 9 Section 1.62 Regulatory Authority................................................. 9 Section 1.63 Royalty Term......................................................... 9 Section 1.64 siRNA................................................................ 9 Section 1.65 siRNA-Attributable Portion........................................... 9 Section 1.66 siRNA Cost of Goods.................................................. 9 Section 1.67
Sample 1
Pivotal Study. If after review of the Pilot Study Report the JSC determines that the results of the Pilot Study as described in the Pilot Study Report meet the success criteria described in the Pilot Study Plan or success criteria otherwise determined by the JSC, and only if the JSC so determines, TALi will submit to the JSC for review and approval a plan for the Pivotal Study (“Pivotal Study Plan,” together with the Pilot Study Plan, the “Study Plans”). The JSC will use all reasonable endeavors to approve the Pivotal Study Plan within [***] ([***]) days of its submission to the JSC, including holding additional meetings of the JSC for this purpose. Prior to accepting the Pivotal Study Plan, the JSC may propose specific amendments to the Pivotal Study Plan that TALi will use all reasonable endeavors to incorporate into any revised Pivotal Study Plan that it may submit to the JSC in substitution for the previous Pivotal Study Plan. Upon JSC approval of the Pivotal Study Plan, TALi will conduct those activities assigned to it under the Pivotal Study Plan in accordance with the timelines therein. Xxxxx will reimburse [***] percent ([***]%) of the direct out-of-pocket costs incurred by TALi for conducting the Pivotal Study, excluding TALi internal costs, provided that such costs were incurred in accordance with the budget set forth in the Pivotal Study Plan, and subject to the maximum Xxxxx reimbursement amount set forth in Section 4.4.
Sample 1
Pivotal Study. “Pivotal Study” shall mean a human clinical trial the results of which could be used as pivotal to establish safety and efficacy of a product as a basis for a marketing approval application submitted to the FDA or the appropriate regulatory authority of such other country, as further defined in 21 CFR §312.21(c), or any successor regulation thereto or foreign equivalents. For clarity, a phase II/III study satisfying the requirements of both a Phase II Study and a Pivotal Study or a Phase II Study satisfying the requirements for regulatory approval, will, for purposes of this Agreement, be deemed both a Phase II Study and a Pivotal Study.
Sample 1

Related to Pivotal Study

  • 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 Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Re-Study If Re-Study of the Interconnection Facilities Study is required due to a higher queued project dropping out of the queue or a modification of a higher queued project pursuant to Section 4.4, Transmission Provider shall so notify Interconnection Customer in writing. Such Re-Study shall take no longer than sixty (60) Calendar Days from the date of notice. Any cost of Re-Study shall be borne by the Interconnection Customer being re-studied.

  • 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 submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all 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, 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 in all material respects and fairly present the data derived from such studies and trials; 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 reasonably 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 written 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.

  • Feasibility Study 4.3.1 The Feasibility Study shall identify any potential adverse system impacts that would result from the interconnection of the Generating Facility.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Trials The Ship shall run the following test and trials:

  • Free Trial If Customer uses a Free Trial Service, PROS will make such Free Trial Service available to Customer on a trial basis, free of charge, until the earlier of (a) the end of the free trial period for which Customer agreed to use such Free Trial Service, (b) the start date of any Subscription Service purchased by Customer for the same service, or (c) termination of the Free Trial Service by PROS in its sole discretion. Additional trial terms and conditions may appear on the trial registration web page. Any such additional terms and conditions are incorporated into this Agreement by reference and are legally binding. Free Trial Services are provided for evaluation purposes and not for production use. Customer shall have sole responsibility and PROS assumes no liability for any Customer Data that Customer may choose to upload on the Free Trial Services. NOTWITHSTANDING SECTION 5 AND 6 ABOVE, FREE TRIAL SERVICES ARE PROVIDED “AS IS” WITH NO EXPRESS OR IMPLIED WARRANTY AND PROS SHALL HAVE NO INDEMNIFICATION OBLIGATIONS, NOR ANY LIABILITY OF ANY TYPE WITH RESPECT TO A FREE TRIAL SERVICE, UNLESS SUCH EXCLUSION OF LIABILITY IS UNENFORCEABLE UNDER APPLICABLE LAW IN WHICH CASE, PROS TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO A FREE TRIAL SERVICE IS US$1,000. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN SECTION 7 ABOVE, CUSTOMER SHALL BE FULLY LIABLE FOR ANY DAMAGES ARISING OUT OF ITS USE OF A FREE TRIAL SERVICE. ANY CUSTOMER DATA AND CONFIGURATIONS ENTERED INTO CUSTOMER’S FREE TRIAL SERVICE ACCOUNT MAY BE PERMANENTLY LOST UPON TERMINATION OF THE FREE TRIAL SERVICE.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

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