PoC Trials Clause Samples

PoC Trials. Cyferd may provide the Customer with or make available to the Customer use of the Cyferd Product (or any part of it including any App(s) and Feature(s)) and the applicable Services for the purposes of a POC Trial. Such use of the Cyferd Product (or any part of it including any App(s) and Feature(s)) and the applicable Services for the purposes of a POC Trial is subject to any additional terms (including any additional Access Parameters and/or Utilisation Parameters) that Cyferd specifies and is only permitted during the period Cyferd expressly designates for such purpose (or, if not so expressly designated, until terminated in accordance with these Terms) and are provided ‘AS-IS’ without indemnification, maintenance, support, or warranty of any kind, express or implied. Except as expressly set out to the contrary in, this clause 6, these Terms and the Agreement, the terms and conditions of these Terms and the Agreement, fully apply in respect of a POC Trial. Cyferd may modify or terminate the Customer’s use of the Cyferd Product (or any part of it including any App(s) and Feature(s)) and/or any of the applicable Services for the purposes of a POC Trial at any time and for any reason in Cyferd’s sole discretion, without liability to the Customer. To the maximum extent permitted by applicable law, Cyferd disclaims all obligations or liabilities with respect to the Customer’s use of the Cyferd Product (including any App(s) and Feature(s)) and the applicable Services for the purposes of a POC Trial including any warranty and indemnity obligations. NOTWITHSTANDING ANYTHING ELSE IN THESE TERMS, CYFERD’S MAXIMUM AGGREGATE LIABILITY TO THE CUSTOMER IN RESPECT OF THE CUSTOMER’S USE OF THE CYFERD PRODUCT AND/OR ANY OF THE SERVICES FOR THE PURPOSES OF A POC TRIAL WILL BE £500 (FIVE HUNDRED POUNDS STERLING).
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PoC Trials. (a) OncoMed shall conduct [***] PoC Trials [***] with respect to [***] Candidate Selection Compounds [***] through to Completion of such PoC Trials. In addition, if OncoMed elects to Develop any antibody under Sections 4.1.5(c), 4.2.7(d), 7.1 and/or 7.2, OncoMed shall use Commercially Reasonable Efforts in accordance with Section 9.1 to conduct [***]. (b) The OncoMed Clinical Trial Plan will serve as a guide for the PoC Trial Design for each Candidate Selection Compound such that, for example, the total number of patients to be treated in the PoC Trials with respect to a Candidate Selection Compound will not exceed the total number of patients set forth in the OncoMed Clinical Trial Plan for such Candidate Selection Compound. The PoC Trial Design for Candidate Selection Compounds in any Program cannot be materially amended after Commencement of the PoC Trials, except upon agreement of the Parties.
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PoC Trials. (a) OncoMed shall conduct [***] PoC Trials [***] with respect to [***] Candidate Selection Compounds [***] through to Completion of such PoC Trials. In addition, if OncoMed elects to Develop any antibody under Sections 4.1.5(c), 4.2.7(d), 7.1 and/or 7.2, OncoMed shall use Commercially Reasonable Efforts in accordance with Section 9.1 to conduct [***]. (b) The OncoMed Clinical Trial Plan will serve as a guide for the PoC Trial Design for each Candidate Selection Compound such that, for example, the total number of patients to be treated in the PoC Trials with respect to a Candidate Selection Compound will not exceed the total number of patients set forth in the OncoMed Clinical Trial Plan for such Candidate Selection Compound. The PoC Trial Design for Candidate Selection Compounds in any Program cannot be materially amended after Commencement of the PoC Trials, except upon agreement of the Parties. (c) Decision-Making Authority Regarding PoC Trials. (i) The JSC, after review of the plan for PoC Trials provided by the JPC pursuant to Section 2.3, will review the indications proposed by the Parties and establish the PoC Trial Design for [***]. If the JSC cannot reach agreement on [***] then such Dispute relating to [***] will be referred to the Executive Officers for resolution pursuant to Section 15.2. If such Executive Officers cannot resolve such Dispute after such escalation, such Dispute shall not be submitted to arbitration and the Parties will not progress such Candidate Selection Compound in any PoC Trial. (ii) After the Parties have agreed upon selection of [***] in accordance with Section 3.6.2(c)(i), [***]. Notwithstanding the foregoing, [***] shall take into account [***]. (iii) In the event the scope and scale of the [***] PoC Trials described in Section 3.6.2(c)(i) are such that the overall scope and scale of the [***] PoC Trials described in Section 3.6.2(c)(i) and (ii) would be [***] than that described in the OncoMed Clinical Trial Plan, then OncoMed shall [***] described in Section 3.6.2(c)(ii).
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Related to PoC Trials

  • 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 or the Prospectus, or the results of which are referred to in the Registration Statement 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 EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement 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 Registration Statement or 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 or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, 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 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.

  • 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.

  • 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.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.