Adverse Event Reporting; Safety Database Sample Clauses

Adverse Event Reporting; Safety Database. Each Operating Party shall be responsible for reporting, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of a Product in its respective Territory (or its respective designated country or region in the Co-Exclusive Territory); provided, that each Operating Party shall consult with the other Operating Party before making any such report. The non-reporting Operating Party shall provide to the reporting Operating Party, upon the reporting Operating Party’s request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to a Product in the Territory. Adverse events related to the use of a Product in the Territory shall be recorded in a single, centralized database for such Product. Such database shall be held, owned and maintained by the Originating Party of such Product at the Originating Party’s expense, which shall be a Development Cost of the Originating Party hereunder. Direct access to the safety database for each Product will be granted to both Operating Parties. Details of safety reporting activities relating to the Product in the Territory will be addressed in a pharmacovigilance agreement, which the Operating Parties shall enter into within ************ following the first Regulatory Approval of such Product.

Related to Adverse Event Reporting; Safety Database

  • 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.

  • 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.

  • MATERIAL SAFETY DATA SHEETS As applicable, Contractor shall provide Purchaser with all appropriate Material Safety Data Sheets (“MSDS”) at the time of delivery of each shipment of Goods which requires such compliance and/or and for materials used by Contractor while performing Services and any updates of the same.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • Account Reporting Information Italian residents who, at any time during the fiscal year, hold foreign financial assets (including cash and shares of Common Stock) which may generate income taxable in Italy are required to report these assets on their annual tax returns (UNICO Form, RW Schedule) for the year during which the assets are held, or on a special form if no tax return is due. These reporting obligations will also apply to Italian residents who are the beneficial owners of foreign financial assets under Italian money laundering provisions.

  • 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.

  • Safety Data Sheets If specified by City in the solicitation or otherwise required by this Contract, Contractor must send with each shipment one (1) copy of the Safety Data Sheet (SDS) for each item shipped. Failure to comply with this procedure will be cause for immediate termination of the Contract for violation of safety procedures.

  • Accident Reporting 25.1 If You or an Authorised Driver has an Accident or if the Vehicle is stolen You must report the Accident or theft to Us within 24 hours of it occurring and fully complete an Accident/Theft report form. 25.2 If the Vehicle is stolen or if You or an Authorised Driver of the Vehicle has an Accident where: (a) any person is injured; (b) the other party has failed to stop or leaves the scene of the Accident without exchanging names and addresses; or (c) the other party appears to be under the influence of drugs or alcohol, You or the Authorised Driver must also report the theft or Accident to the Police. 25.3 If You or an Authorised Driver has an Accident You and the Authorised Driver must: (a) exchange names and addresses and telephone numbers with the other driver and drivers licence details; (b) take the registration numbers of all vehicles involved; (c) take as many photos as is reasonable showing: (i) the position of the Vehicles before they are moved for towing or salvage; (ii) the Damage to the Vehicle; (iii) the damage to any third party vehicle or property; and (iv) the general area where the Accident occurred, including any road or traffic signs; (d) obtain the names, addresses and phone numbers of all witnesses; (e) not make any admission of fault or promise to pay the other party's claim or release the other party from any liability; (f) forward all third party correspondence or court documents to Us within 7 days of receipt together with a fully completed Accident Report Form (if not already submitted); and (g) co-operate with Us in the prosecution of any legal proceedings that We may institute or defence of any legal proceedings which may be instituted against You or Us as a result of an Accident, including: (i) attending Our lawyer's office; and (ii) any Court hearing.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.