Exchange of Adverse Event Information Sample Clauses

Exchange of Adverse Event Information. Without delay, each party agrees to provide the other party and any other licensees or sublicensees with any serious adverse event information of which it becomes aware, including but not limited to post-market surveillance information, which may be required to be provided to regulatory authorities in any jurisdiction. Such information shall be provided as soon as possible, and all non-serious adverse event information shall be exchanged between the parties at least quarterly. DTI shall disclose to Xxxxxxx the names of all DTI's licensees in order to allow the exchange of information provided for in this Section 3.10 between Xxxxxxx and DTI's licensees.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Exchange of Adverse Event Information. (a) Within sixty (60) days of their respective submission, Fujisawa shall provide DTI with copies of that portion of the IND and NDA Annual Reports submitted by Fujisawa with the FDA and any other similar reports submitted with the applicable regulatory authority in Canada that address adverse event matters arising from the use of Licensed Products. Fujisawa shall provide DTI with copies of IND Safety Reports within three (3) days of their submission by Fujisawa to the FDA. Following Regulatory Approval for each Licensed Product in the United States (and Canada if applicable), Fujisawa shall provide DTI with copies of those Periodic Adverse Event Reports submitted by Fujisawa to the FDA or other applicable regulatory authority in Canada which relate to each Licensed Product. Such adverse event reports shall be provided by Fujisawa to DTI within thirty (30) days of their submission by Fujisawa to the FDA or such other regulatory authority. (b) Fujisawa shall provide DTI with copies of 15-Day Alert Reports within three (3) days of their submission by Fujisawa to the FDA. Fujisawa shall report these expedited reports on FDA MedWatch forms. Fujisawa shall notify the contact person designated by DTI by fax at (000) 000-0000 or telephone at (804) 000-0000, as may be revised. DTI shall be responsible for reporting to Fujisawa all serious adverse event reports occurring with each Licensed Product during the Phase I Injectable Protocol within three (3) days of receipt by DTI. Serious adverse events shall be designated using the current FDA definition of the term "serious". DTI shall provide Fujisawa with listings of all non-serious adverse events occurring with each Licensed Product during the Phase I Trial annually and at the completion of the study. Completion of a study shall be defined, for purposes of this Section 4.5(b) only, as that period of time one (1) week following Fujisawa's approval of the final study report. After launch of the Licensed Products, DTI shall be responsible for reporting to Fujisawa all serious adverse events associated with the Licensed Products of which DTI becomes aware, whether within or outside the Territory, within twenty four (24) hours after DTI becomes aware of such serious adverse event. DTI shall notify Fujisawa of any non-serious adverse events associated with the Licensed Products within the Territory of which DTI becomes aware within ten (10) days of DTI becoming aware of the non-serious adverse event. DTI shall report to ...
Sample 1Sample 2
Exchange of Adverse Event Information. The language of all exchanges of AE information will be English. Each Party can also elect not to receive documents. If both Parties have the capabilities, by mutual agreement, data exchange can be done electronically.
Sample 1Sample 2
Exchange of Adverse Event Information. The recipient of Adverse Event (AE) reports and/or data, either Distributor or Ligand, will mutually exchange and promptly provide in writing, using the latest applicable International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) guidelines for reporting, any adverse event information obtained by the receiving party associated with the use of the Products either as a result of marketed use or from investigational clinical trials: (a) Without limiting the foregoing, the party that is the original recipient of AE information relating to incidents of serious and unexpected reactions and/or events associated with the use of any of the Products, as defined by the ICH and/or CIOMS guidelines, shall make an initial written report of that information to the other party, via facsimile, not more than 72 hours following receipt of that information. A full written report, following the content and format guidelines indicated in the applicable current ICH and CIOMS guidelines, is to be sent to and received by the other party within seven (7) days following the date the initial recipient receives such AE information. (b) Distributor shall also provide Ligand with routine quarterly and annual adverse event reports and/or safety data received from any source in the Territory, using the ICH guidelines for the content and format for these types of reports. These reports are intended to be used for and incorporated into Periodic Safety Update Reports [PSUR] as defined by ICH guidelines. Ligand will provide a copy of each of the Products' complete PSUR to the Distributor within five (5) days of submission of the applicable Product's PSUR to the U.S. regulatory authorities. (c) Distributor shall be responsible for submitting the adverse event/ medical safety (safety surveillance) reports in the countries of the Territory as required by the regulatory authorities. Ligand will hold and maintain the Central AE/ safety database for the Products and reports based on this
Sample 1

Related to Exchange of Adverse Event Information

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Event Information Number: 220702 Title: Temporary Flood Barriers Type: Request for Proposal Issue Date: 7/7/2022 Deadline: 8/19/2022 03:00 PM (CT) Notes: I F YO U CURRENTL Y HOL D TIP S CONTRAC T 190702 TEMPORARY FLOOD BARRIERS ("190702"), YOU MUST RESPOND TO THIS SOLICITATION TO PREVENT LAPSE OF CONTRACT UNLESS YOU HOLD ANOTHER CURRENT TIPS CONTRACT THAT COVERS ALL OF YOUR TEMPORARY FLOOD BARRIER OFFERINGS. THIS AWARDED CONTRACT WILL REPLACE YOUR EXPIRING TIPS CONTRACT 190702. Address: Region 8 Education Service Center 0000 XX Xxxxxxx 000 Xxxxx Pittsburg, TX 75686 Phone: +0 (000) 000-0000 Email: xxxx@xxxx-xxx.xxx Contact: Xxxxxxx Xxxx Address: 000 Xxxxx Xxxxxx, Xxxx X Kenner, LA 70062 Phone: (000) 000-0000 Email: xxxxxxx@xxxxxxxxxxxxxx.xxx Web Address: xxxxx://xxxxxxxxxxxxxx.xxx/ By submitting your response, you certify that you are authorized to represent and bind your company. If you have not taken exception or deviation to the agreement language in the solicitation attributes, download the AGREEMENT SIGNATURE FORM from the "ATTACHMENTS" tab. This PDF document is a fillable form. Download the document to your computer, fill in the requested company information, print the file, SIGN the form, SCAN the completed and signed AGREEMENT SIGNATURE FORM, and upload here. If you have taken exception to any of the agreement language and noted the exception in the deviations section of the attributes for the agreement, complete the AGREEMENT SIGNATURE FORM, but DO NOT SIGN until those deviations have been negotiated and resolved with TIPS management. Upload the unsigned form here, because this is a required document. All Other Certificates (if applicable) must be scanned and uploaded. If vendor has more than one other certification scan into one document. (PDF Format ONLY) DO NOT UPLOAD encrypted or password protected files. The vendor must download the PRICING SPREADSHEET SHEET from the attachment tab, fill in the requested information and upload the completed spreadsheet. DO NOT UPLOAD encrypted or password protected files.

  • Market Information Exchange and Xxxxxxxxxx brochures and research are often provided as trading tools. In addition, a CTS Platform may also contain certain market information. Customer acknowledges that: (a) any information Xxxxxxxxxx’x research department may communicate to Customer does not constitute an offer to sell or a solicitation of any offer to buy any Contract; (b) such recommendations and information, although based upon information obtained from sources believed by Xxxxxxxxxx to be reliable, are incidental to Xxxxxxxxxx’x business as a futures commission merchant, may be incomplete and not subject to verification, and will not serve as the primary basis for any decision by Customer; (c) Xxxxxxxxxx makes no representation, warranty, or guarantee as to, and shall not be responsible for, the accuracy or completeness of any information or trading recommendation furnished to Customer; (d) recommendations to Customer as to any particular transaction at any given time may differ among Xxxxxxxxxx’x personnel due to diversity in analysis of fundamental and technical factors and may vary from any standard recommendation made by Xxxxxxxxxx in its market letters or otherwise; and (e) Xxxxxxxxxx has no obligation or responsibility to update any market recommendations or information it communicates to Customer. Customer understands that Xxxxxxxxxx and its officers, directors, affiliates, stockholders, representatives, or associated persons may have positions in and may intend to buy or sell Contracts which are the subject of market recommendations furnished to Customer, and that the market positions of Xxxxxxxxxx or any such officer, director, affiliate, stockholder, representative, or associated person may or may not be consistent with the recommendations furnished to Customer by Xxxxxxxxxx.

  • 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.

  • 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.

  • Factsheet Information General information entered into the higher education institutions’ profile and updated by the higher education institution. The general information about the institution is accessible to students. Autumn term [day/month] 04/30 Spring term [day/month] 09/30 Autumn term [day/month] 06/30 Spring term [day/month] 11/30 xxxxxxxx@xxxxxx.xxx.xx +000000000000 xxxxx://xxxxxxx.xxxxxx.xxx.xx/en Requirement Details Website Other Transcript xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/Erasmus--Europe/How-to-Apply/82 2 Other Copy of Passport xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/Erasmus--Europe/How-to-Apply/82 2 Other Learning Agreement xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/Erasmus--Europe/How-to-Apply/82 2 Available infrastructure ad- justed for people with: Description of infras- tructure Contact details Website for information Infrastructure Not present xxxxx://xxxxxxx.xxxxxx.xxx.xx /en The institution will guide incoming mobile participants in finding accommodation, according to the requirements of the Erasmus Charter for Higher Education. Information and assistance can be provided by the following contact points and information sources: Contact email Contact phone Websites for information xxxxxxxx@xxxxxx.xxx.xx +000000000000 xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/16/Accom modation/474 The institution will provide assistance, when required, in securing visas for incoming and outbound mobile partici- pants, according to the requirements of the Erasmus Charter for Higher Education. Information and assistance can be provided by the following contact points and information sources: Contact email Contact phone Websites for information xxxxxxxx@xxxxxx.xxx.xx +000000000000 xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/16/Visa-an d-Residence-Permit/472 The institution will provide assistance in obtaining insurance for incoming and outbound mobile participants, accord- ing to the requirements of the Erasmus Charter for Higher Education. The receiving institution will inform mobile par- ticipants of cases in which insurance cover is not automatically provided. Information and assistance can be provided by the following contact points and information sources: Contact email Contact phone Websites for information xxxxxxxx@xxxxxx.xxx.xx +000000000000 xxxxx://xxxxxxx.xxxxxx.xxx.xx/page/16/Healt h-Insurance/473

  • Statement of Additional Information The Manager shall determine from time to time what securities and other investments will be purchased (including, as permitted in accordance with this paragraph, swap agreements, options and futures), retained, sold or exchanged by the Fund and what portion of the assets of the Funds portfolio will be held in the various securities and other investments in which the Fund invests, and shall implement those decisions (including the execution of investment documentation), all subject to the provisions of the Trusts Declaration of Trust and By-Laws (collectively, the Governing Documents), the 1940 Act, and the applicable rules and regulations promulgated thereunder by the Securities and Exchange Commission (the SEC) and interpretive guidance issued thereunder by the SEC staff and any other applicable federal and state law, as well as the investment objectives, policies and restrictions of the Fund referred to above, and any other specific policies adopted by the Board and disclosed to the Manager. The Manager is authorized as the agent of the Trust to give instructions to the custodian of the Fund as to deliveries of securities and other investments and payments of cash for the account of the Fund. Subject to applicable provisions of the 1940 Act and direction from the Board, the investment program to be provided hereunder may entail the investment of all or substantially all of the assets of the Fund in one or more investment companies. The Manager will place orders pursuant to its investment determinations for the Fund either directly with the issuer or with any broker or dealer, foreign currency dealer, futures commission merchant or others selected by it. In connection with the selection of such brokers or dealers and the placing of such orders, subject to applicable law, brokers or dealers may be selected who also provide brokerage and research services (as those terms are defined in Section 28(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act)) to the Funds and/or the other accounts over which the Manager or its affiliates exercise investment discretion. The Manager is authorized to pay a broker or dealer who provides such brokerage and research services a commission for executing a portfolio transaction for the Fund which is in excess of the amount of commission another broker or dealer would have charged for effecting that transaction if the Manager determines in good faith that such amount of commission is reasonable in relation to the value of the brokerage and research services provided by such broker or dealer. This determination may be viewed in terms of either that particular transaction or the overall responsibilities which the Manager and its affiliates have with respect to accounts over which they exercise investment discretion. The Board may adopt policies and procedures that modify and restrict the Managers authority regarding the execution of the Funds portfolio transactions provided herein. The Manager shall also provide advice and recommendations with respect to other aspects of the business and affairs of the Fund, shall exercise voting rights, rights to consent to corporate action and any other rights pertaining to the Fund's portfolio securities subject to such direction as the Board may provide, and shall perform such other functions of investment management and supervision as may be directed by the Board. The Manager may execute on behalf of the Fund certain agreements, instruments and documents in connection with the services performed by it under this Agreement. These may include, without limitation, brokerage agreements, clearing agreements, account documentation, futures and option agreements, swap agreements, other investment related agreements, and any other agreements, documents or instruments the Manager believes are appropriate or desirable in performing its duties under this Agreement.

  • Patient Information Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information and/or patients’ protected health information, as defined by any other applicable legislation in the course of their performance under this Agreement.

  • zone Information Publication ICANN’s publication of root-zone contact information for the TLD will include Registry Operator and its administrative and technical contacts. Any request to modify the contact information for the Registry Operator must be made in the format specified from time to time by ICANN at xxxx://xxx.xxxx.xxx/domains/root/.

  • Client Information Protected Health Information in any form including without limitation, Electronic Protected Health Information or Unsecured Protected Health Information (herein “PHI”);

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!