Conduct of Study Provádění Studie
Conduct of Study Provádění Studie Sample Clauses
Related to Conduct of Study Provádění Studie
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.
Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.
Submission and Approval The Contractor’s Submittals must comply with the Contract Documents. The Contractor shall review and approve all Submittals prior to submission. The Contract Documents shall specify when shop drawings or submittals require the seal of a specialty consultant. The Contractor shall submit copies of Submittals as required by the Contract Documents for the Work of the various trades. The Design Professional shall review, approve, or take other appropriate action with respect to shop drawings, samples, or other submissions of the Contractor, including, but not limited to, confirming conformance with the design concept of the Project and with the Contract Documents. The Design Professional shall respond to and return said items to the Contractor within fourteen calendar days from receipt provided that the Submittals are submitted by the Contractor in accordance with the required Submittal schedule. The Design Professional shall review and give comment or approval to Submittal schedule within fourteen calendar days from receipt. Large submittal documents may require longer review times, e.g., submittals with over fifty sheets of drawings. If, because of events beyond its reasonable control, the Design Professional is not able to meet the specified time period, then it is entitled to ask for additional time from the Owner. The Contractor shall make all corrections required by the Design Professional and furnish such corrected copies as may be needed. If the Contractor believes that any corrections required by the Design Professional constitute a change to the contract, the Contractor shall immediately notify the Design Professional and Owner and request instructions. By forwarding the approved Submittals to the Design Professional, the Contractor represents that the Contractor has determined and verified materials, field measurements, and field construction criteria related thereto, or will do so, and has checked and coordinated the information contained within such Submittals with the requirements of the Work and of the Contract Documents. The Design Professional’s approval of Submittals shall not relieve the Contractor from the responsibility for errors of any sort in Submittals or schedules. The Contractor shall perform no portion of the Work for which the Contract Documents require Submittals until the Design Professional has approved the respective Submittal. The Contractor shall maintain at the Site one copy of all approved Submittals.
Inspection and Approval All works embracing more than one process shall be subject to examination and approval at each stage thereof and the Contractor shall given due notice to the Engineer-in-Charge or his authorized representative when each stage is ready. In default of such notice the Engineer-in- Charge shall be entitled to appraise the quality and extent thereof.
Trials The Ship shall run the following test and trials:
Limitation on Out-of-State Litigation - Texas Business and Commerce Code § 272 This is a requirement of the TIPS Contract and is non-negotiable. Texas Business and Commerce Code § 272 prohibits a construction contract, or an agreement collateral to or affecting the construction contract, from containing a provision making the contract or agreement, or any conflict arising under the contract or agreement, subject to another state’s law, litigation in the courts of another state, or arbitration in another state. If included in Texas construction contracts, such provisions are voidable by a party obligated by the contract or agreement to perform the work. By submission of this proposal, Vendor acknowledges this law and if Vendor enters into a construction contract with a Texas TIPS Member under this procurement, Vendor certifies compliance.
Special Studies Providing planning services, site evaluations, environmental studies, or comparative studies of prospective sites, preparing special surveys, studies, and submissions required under Applicable Law.
Application and Approval (a) 1. An employee shall make written application to her Employer on or before January 31st of the year in which the deferment is to commence, requesting permission to participate in the Plan.
Feasibility Study Buyer will, at Buyer's expense and within ____ days from Effective Date ("Feasibility Study Period"), determine whether the Property is suitable, in Buyer's sole and absolute discretion, for ___________________ use. During the Feasibility Study Period, Buyer may conduct a Phase I environmental assessment and any other tests, analyses, surveys and investigations ("Inspections") that Buyer deems necessary to determine to Buyer's satisfaction the Property's engineering, architectural and environmental properties; zoning and zoning restrictions; subdivision statutes; soil and grade; availability of access public roads, water, and other utilities; consistency with local, state and regional growth management plans, availability of permits, government approvals, and licenses; and other inspections that Buyer deems appropriate to determine the Property's suitability for the Buyer's intended use. If the Property must be rezoned, Buyer will obtain the rezoning from the appropriatx xxxernment agencies. Seller will sign all documents Buyer is required to file in connection with development or rezoning approvals. Seller gives Buyer, its agents, contractors and assigns, the right to enter the Property at any time during the Feasibility Study Period for the purpose of conducting inspections; provided, however, that Buyer, its agents, contractors and assigns enter the Property and conduct inspections at their own risk. Buyer will indemnify and hold Seller harmless from xxxxes, damages, costs, claims and expenses of any nature, including attorney's fees, expenses and liability incurred in application for rezoning or related proceedings, and from liability to any person, arising from the conduct of any and all inspections of any work authorized by Buyer. Buyer will not engage in any activity that xxxxx result in a construction lien being filed against the Property without Seller's prior written consent. If this transaction does not close, Buyer will, at Buyer's expense, (1) repair all damages to the Property resulting from the Inspections and return the Property to the condition it was in prior to conduct of the Inspections, and (2) release to Seller all reports and other work generated as a result of the Inspections. Buyer will deliver written notice to Seller prior to the expiration of the Feasibility Study Period of Buyer's determination of whether or not the Properxx xx acceptable. Buyer's failure to comply with this notice requirement will constitute acceptance of the Property as suitable for Buyer's intended use in its "as is" condition. If the Property is unacceptable to Buyer and written notice of this fact is timely delivered to Seller, this Contract will be deemed terminated as of the day after the Feasibility Study period ends and Buyer's deposit(s) will be returned after Escrow Axxxx receives proper authorization form all interested parties.
Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
