Phase III Studies Clause Samples

The 'Phase III Studies' clause defines the requirements and expectations for conducting large-scale clinical trials, typically the final phase before seeking regulatory approval for a new drug or treatment. This clause outlines the scope, objectives, and responsibilities related to these studies, such as the number of participants, endpoints to be measured, and compliance with regulatory standards. Its core function is to ensure that both parties understand the standards and obligations for pivotal clinical trials, thereby facilitating successful product development and regulatory submission.
Phase III Studies. 13 1.19 Product................................................................ 13 1.20 Program Inventions and Joint Program Inventions........................ 13 1.21
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Phase III Studies. The current Phase III program has been developed based upon the target indications, the expectations of the Parties and the current understanding of regulatory agency requirements in North America. The final Phase III program will be developed based upon available Phase II clinical data on the h5G1.1-scFv, relevant data from agents with similar potential indications, discussions with clinical experts and thought leaders, and discussions with the FDA and other regulatory agencies. The following studies are envisioned for Phase III: - A double-blind, placebo-controlled, study of the effect of h5G1.1-scFv on total mortality and adverse cardiovascular ischemic outcomes in patients undergoing cardiopulmonary bypass - A double-blind, placebo-controlled study of the effect of h5G1.1-scFv on mortality and non-fatal reinfarction in acute MI patients treated with thrombolytic therapy. - A double-blind, placebo-controlled study of the effect of h5G1.1-scFv on acute cardiac ischemic complications (death, non-fatal myocardial infarction, urgent intervention by CABG, repeat PTCA or stent) in patients at high risk for abrupt closure of a coronary vessel. Alexion and/or P&G will provide oversight of investigator sites participating in clinical trials of the Product.
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Phase III Studies. If KV has not given notice of its intention to terminate this Agreement within the 30 day period contemplated in Section 2.2(a), that FemmePharma will commence and obtain Phase III Studies of the Initial Product (subject to the receipt of an adequate supply of Initial Product from KV to conduct the Phase III Studies, in accordance with the second sentence of Section 3.1) according to the protocol, clinical plan and clinicians set forth in Appendix E, as the same may be amended upon ---------- mutual agreement of the parties as and to the extent necessary to obtain regulatory approval of the Initial Product, which Phase III Studies shall be sufficient to obtain FDA approval of an NDA for the Initial Product. During the period during which such studies are being conducted, KV shall have the right to visit, upon one business day's notice to FemmePharma and only to the extent permitted under applicable FDA regulations, the clinical study sites which are participating therein and to review and discuss the work records and the progress and results of the studies with the clinicians involved in the studies.
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Phase III Studies. When the last Phase III study relating to the first SansRosa Product is clinically complete, and CollaGenex has determined that the results of the Phase III studies support a decision to assemble and submit a New Drug Application to the U.S. Food and Drug Administration (the “FDA), CollaGenex shall purchase, and the Shareholders shall deliver to CollaGenex, 4% of the Shares at a price per share that results in the aggregate consideration payable at such time being $[**];
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Phase III Studies. Except for SANOFI-SYNTHELABO IL-13 Development Programs that are governed by the 2001 Agreement: – IDM agrees to carry out at its sole expense Phase III Studies of IL-13 Development Programs and to use its best efforts to complete such Phase III Studies at the earliest possible time compatible with applicable legal and regulatory requirements. – IDM shall provide SANOFI-SYNTHELABO with semi-annual progress reports on Phase III Studies and shall keep SANOFI-SYNTHELABO informed as soon as possible about any problem that could have a significant negative effect on said Phase III Studies. – Representatives of IDM and SANOFI-SYNTHELABO shall meet, at the request of either Party, to discuss the contents of semi-annual progress reports on Phase III Studies as provided by IDM. During these meetings, IDM will provide any supplementary information that SANOFI-SYNTHELABO might reasonably request about the results of Phase III Studies, to the extent this additional information is available on the date of the request by SANOFI-SYNTHELABO, and does not require any additional research or investigations beyond those conducted by IDM. – IDM will provide SANOFI-SYNTHELABO with a summary report on Phase III Studies carried out on one or more of the IL-13 Products within sixty (60) days following the completion of these Phase III Studies.
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Phase III Studies 
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Related to Phase III Studies

  • 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 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.

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

  • 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.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in ▇▇▇▇ rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.