Adverse Events Documentation. PFIZER will provide to LICENSEE a summary of any and all adverse events reported to PFIZER for clinical trials of ETC-216, including specific narratives and attributions for serious adverse events.
Adverse Events Documentation Sample Clauses
Related to Adverse Events Documentation
Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.
Project Documentation All documentation provided to the City other than Project drawings shall be furnished on a Microsoft compatible compact disc.
Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. Claims can arise, under certain types of insurance contract, long after the expiry of the policy. It is therefore important that you retain and keep safely all documents associated with your policy.
Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet
Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO. b. A description or identification of the statistical sampling software package used by the IRO.
Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.
ENVIRONMENTAL DOCUMENTATION Each environmental service provided by the Engineer shall have a deliverable. Deliverables shall summarize the methods used for the environmental services, and shall summarize the results achieved. The summary of results shall be sufficiently detailed to provide satisfactory basis for thorough review by the State, The Federal Highway Administration (FHWA), and (where applicable) agencies with regulatory oversight. All deliverables shall meet regulatory requirements for legal sufficiency, and shall adhere to the requirements for reports enumerated in the State’s NEPA MOU. a. Quality Assurance/Quality Control Review For each deliverable, the Engineer shall perform quality assurance quality control (QA/QC) reviews of environmental documents and on other supporting environmental documentation to determine whether documents conform with: 1) Current Environmental Compliance Toolkit guidance published by the State’s Environmental Affairs Division and in effect as of the date of receipt of the documents or documentation to be reviewed; 2) Current state and federal laws, regulations, policies, guidance, agreements, and memoranda of understanding between the State and other state or federal agencies; and 3) FHWA and American Association of State Highway and Transportation Officials (AASHTO) guidelines contained in “Improving the Quality of Environmental Documents, A Report of the Joint AASHTO and American Council of Engineering Companies (ACEC) Committee in Cooperation with the Federal Highway Administration” (May 2006) for: DocuSign Envelope ID: F9E4AA24-4672-4529-8EFA-00D1CA218520 a) Readability, and b) Use of evidence and data in documents to support conclusions. Upon request by the State, the Engineer shall provide documentation that the QA/QC reviews were performed by qualified staff. b. Deliverables shall contain all data acquired during the environmental service. All deliverables shall be written to be understood by the public and must be in accordance with the State’s Environmental Toolkit guidance, documentation standards, current guidelines, policies and procedures. c. Electronic versions of each deliverable must be written in software which is compatible to the State and must be provided in a changeable format for future use by the State. The Engineer shall supplement all hard copy deliverables with electronic copies in searchable Adobe Acrobat™ (.pdf) format, unless another format is specified. Each deliverable shall be a single, searchable .pdf file that mirrors the layout and appearance of the physical deliverable. The Engineer shall deliver the electronic files on CD-R, CD-RW media in Microsoft Windows format, or through the ftp site. d. When the environmental service is to apply for a permit (e.g., United States Coast Guard (USCG) or United States Army Corps of Engineers (USACE), the permit and all supporting documentation shall be the deliverable. e. Submission of Deliverables 1) Deliverables shall consist of reports of environmental services performed in addition to a Categorical Exclusion (CE) determination form and supporting documentation including the required form or Environmental Assessment (EA) document, when applicable. 2) All deliverables must comply with all applicable state and federal environmental laws, regulations and procedures and include all items listed in the Environmental Document Review Checklist and the Administrative Completeness Review Checklist. 3) On the cover page of each environmental assessment (EA), finding of no significant impact (XXXXX), environmental impact statement (EIS), and record of decision (ROD) prepared under the authority granted by this MOU, and for any memorandum corresponding to any CE determination it makes, the Engineer shall insert the following language in a way that is conspicuous to the reader or include it in a CE project record: "The environmental review, consultation, and other actions required by applicable DocuSign Envelope ID: F9E4AA24-4672-4529-8EFA-00D1CA218520 Federal environmental laws for this project are being, or have been, carried-out by TxDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT." f. The State shall provide the State’s and other agency comments on draft deliverables to the Engineer. The Engineer shall revise the deliverable: 1) to include any State commitments, findings, agreements, or determinations (e.g., wetlands, endangered species consultation, Section 106, or Section 4(f)), required for the Transportation Activity as specified by the State; 2) to incorporate the results of public involvement and agency coordination; 3) to reflect mitigation measures resulting from comments received or changes in the Transportation Activity; and 4) include with the revised document a comment response form (matrix) in the format provided by the State. g. All photographs shall be 3.5” x 5” color presentation printed on matte finish photographic paper or 3.5” x 5” color presentation printed on matte white, premium or photo quality laser or inkjet paper. All photographs shall be well focused and clearly depict details relevant to an evaluation of the project area. Provision of photographs shall be one original print of each image or electronic presentations of comparable quality. Comparable quality electronic photograph presentations shall be at least 1200 x 1600 pixel resolution. Photographs shall be attached to separately labeled pages that clearly identify project name, project identification (ID) number, address or Universal Transverse Mercator (UTM) of resource, description of the picture and direction of the photographic view. In addition to the hard-copy prints, an electronic version of each will be submitted with the same identification information as the hard-copy.
Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.
Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.
Meteorological Data Reporting Requirement (Applicable to wind generation facilities only)
