Accident Reports/Adverse Event Reporting Sample Clauses

Accident Reports/Adverse Event Reporting. It is understood and agreed that FibroGen (or other Recipients) shall have the sole right and responsibility for reporting to the applicable and appropriate Regulatory Authorities any adverse events involving a Product or Final Product (as applicable). STA shall provide FibroGen all reasonable assistance in complying with such reporting requirements. STA shall report to FibroGen immediately within [ ] ([ ]) business days all material accidents related to the manufacture, handling, use or storage of any Raw Materials, FibroGen Materials, or Product, including, without limitation: (a) accidents resulting in significant personal injury requiring more than first aid treatment, (b) accidents resulting in chronic illness or loss of consciousness, (c) accidents resulting in material property damage, (d) accidents resulting in material environmental release, and (e) accidents that result in regulatory, safety, health or environmental audits. STA shall notify FibroGen, in accordance with the requirements of the Quality Agreement if set forth therein, of any information of which STA becomes aware concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, that is associated with the manufacturing of Product.
Sample 1
AutoNDA by SimpleDocs
Accident Reports/Adverse Event Reporting. Responsibilities with respect to pharmacovigilance and the reporting of adverse events and accident reports shall be set forth in a safety data exchange agreement to be agreed by the Parties prior to the first prescription of Finished Product by Astellas.
Sample 1
Accident Reports/Adverse Event Reporting. It is understood and agreed that FibroGen (or other Designees) shall have the sole right and responsibility for reporting to the applicable and appropriate Regulatory Authorities any adverse events involving the Product or Final Product (as applicable). Catalent shall provide FibroGen all reasonable assistance in complying with such reporting requirements. Catalent shall report to FibroGen immediately within [ ] ([ ]) business day all material accidents related to the manufacture, handling, use or storage of any Raw Materials, FibroGen-supplied Materials, or Product, including, without limitation: (a) accidents resulting in significant personal injury requiring more than first aid treatment, (b) accidents resulting in chronic illness or loss of consciousness, (c) accidents resulting in material property damage, (d) accidents resulting in material environmental release, and (e) accidents that result in regulatory, safety, health or environmental audits. Catalent shall notify FibroGen of any information of which Catalent becomes aware concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, that is associated with the manufacturing of Product.
Sample 1

Related to Accident Reports/Adverse Event Reporting

  • 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.

  • 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.

  • Accident Reports If any of the Equipment is damaged, lost stolen, or destroyed, or if any person is injured or dies, or if any property is damaged as a result of its use, maintenance, or possession, You will promptly notify Us of the occurrence, and will file all necessary accident reports, including those required by law and those required applicable insurers. You, Your employees, and agents will cooperate fully with Us and all insurers providing insurance under this Agreement in the investigation and defense of any claims. You will promptly deliver to Us any documents served or delivered to You, Your employees, or Your agents in connection with any claim or proceeding at law or in equity begun or threatened against You, Us, or both You and Us.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

  • 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.

  • Incident Reports Any serious occurrence involving a beneficiary, outside the normal routine of the OTP (see TRICARE Operations Manual (XXX), Chapter 7, Section 4), shall be reported to the referring military providers and/or Military Treatment Facility (MTF)/Enhanced Multi-Service Market (eMSM) referral management office (on behalf of the military provider), and DHA, and/or a designee, as follows: (a) An incident of a life-threatening accident, patient death, patient disappearance, suicide attempt, incident of cruel or abusive treatment, or any equally dangerous situation involving a beneficiary, shall be reported by telephone on the next business day with a full written report within seven days. (b) The incident and the following report shall be documented in the patient’s clinical record. (c) Notification shall be provided, if appropriate, to the parents, legal guardian, or legal authorities.

  • 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.

  • Security Incident Reporting A security incident occurs when CDA information assets are or reasonably believed to have been accessed, modified, destroyed, or disclosed without proper authorization, or are lost, or stolen. Subrecipient must comply with CDA’s security incident reporting procedures located at xxxxx://xxx.xxxxx.xx.xxx/ProgramsProviders/#Resources.

  • 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.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

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