Safety Agreement. All pupils use computer facilities including internet access as an essential part of learning, as required by the National Curriculum. Pupils are asked to sign to show that the Acceptable Use and e-Safety rules have been understood and agreed.
Safety Agreement. Promptly after the Effective Date and before the date that Licensee commences any clinical trials of the Licensed Product in the Territory, the Parties shall enter into a separate written safety agreement containing (i) appropriate provisions addressing safety issues relating to the Licensed Products, (ii) a description of the types of side effects and reactions that must be reported pursuant to Section 7.6(a) and any other complaints or information requests that must be reported, and (iii) such cooperative working procedures as are reasonably necessary to ensure that satisfactory systems and processes are in place to ensure the effective exchange of safety and other medical information relating to the Licensed Product (the “Safety Agreement”).
Safety Agreement. The Parties shall execute a Safety Agreement in the form attached in Schedule 5 at the same time as the execution of this Agreement.
Safety Agreement. Promptly after the Effective Date, but in any event no later than the date of initiation of a Clinical Trial by Astellas in the Territory, the Parties shall enter into a safety agreement governing the Parties’ respective obligations with respect to allocation of responsibilities for reporting to the other Party and appropriate Regulatory Authorities adverse events, complaints, and other safety-related matters. Astellas shall be responsible for creation and maintenance of the global safety database for Products following the date agreed by the JSC.
Safety Agreement. All pupils use computer facilities including internet access as an essential part of learning, as required by the National Curriculum. Pupils are asked to sign to show that the Acceptable Use and e0Safety rules have been understood and agreed. Use of Computers in the School/Academy The School/Academy owned equipment and network must be used appropriately ✓ The computer system is available for educational use only ✓ I will only log on with my own username and password ✓ I understand the School/Academy monitors use of the information systems ✓ Printing – I will make sure my work is finished and checked and only print when instructed to do so ✓ I will take care when using the equipment so as not to cause damage ✓ If I do not follow these rules then I might have to speak to my Head of Year or my parents/carers might have to talk to the Headteacher/Principal about what I have done These rules help us to stay safe on the Internet: ✓ I ask permission before using the Internet ✓ I only use websites that an adult has chosen or helped me choose ✓ I tell an adult immediately if I see or read anything I am uncomfortable with and switch my screen off ✓ I send emails that are polite and friendly ✓ I never give out personal information about myself or others or passwords ✓ I never arrange to meet anyone I don’t know ✓ I do not open emails sent by anyone I don’t know ✓ I do not use Internet chat rooms ✓ I am not allowed to connect personal devices to the School/Academy network ✓ I will only post content online if it is appropriate and I have permission This sheet can be kept at home for discussion as necessary This sheet is to be printed off, signed and returned to the Class Teacher. [ENTER SCHOOL/ACADEMY NAME] Pupil Acceptable Use & E-Safety Agreement Pupil’s Agreement I have read and I understand the School/Academy Acceptable Use and E-Safety Rules. I will use the computers, network, Internet, email (with permission) and other new technologies in a responsible way at all times. I know that my network, Internet and email use may be monitored. Childs Name (Print) Class Year Parent’s Agreement Name (Print) Signature Date Appendix 3 - PUPIL ACCEPTABLE USE AGREEMENT [FOR INFANT & NURSERY] I am safe agreement I will use the internet with an adult I will only use programmes an adult says are safe I will be friendly and polite when I use the computer I will tell an adult if I see something I do not like I will keep my log in and password private Signed: (Child)
Safety Agreement. No later than one year before the First Commercial Sale, the Parties will enter into a written agreement setting forth worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products (the “Safety Agreement”). The Safety Agreement will describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting, and exchange of information between the Parties concerning any adverse event experienced by a subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to any Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) and will be sufficient to permit each Party and its Affiliates, licensees, or Sublicensees (as applicable) to comply with its legal obligations with respect thereto, including the obligations as the owner or holder of Regulatory Approvals and Pricing Approvals for such Licensed Product as applicable. The Safety Agreement will also detail each Party’s responsibilities with respect to recalls and withdrawals of the Licensed Products inside and outside of the Territory. If required by changes in Applicable Law, the Parties will make appropriate updates to the Safety Agreement. Each Party will comply with its respective obligations under the Safety Agreement and cause its Affiliates, licensees, and Sublicensees to comply with such obligations. Notwithstanding any provision to the contrary in this Agreement or the Safety Agreement, each Party and its Affiliates, licensees, and Sublicensees will have the right to disclose information related to the safety of one or more Licensed Products to the extent that such disclosure is required for such Party to comply with its obligations under Applicable Law or the safety requirements of the applicable Regulatory Authorities. The Parties will cooperate with each other to address any safety-related inquiries or requests for safety assessment by any Regulatory Authority, including providing any necessary data or information in a timely manner. To the extent that there is a conflict between the terms of this Agreement and the terms of the Safety Agreement, the terms of the Safety Agreement will govern with respect to the subject matter set forth therein.
Safety Agreement. Within [***] months of the Effective Date of this Agreement, the JSC will develop a mutually acceptable safety agreement (to be agreed upon and executed by both Parties) setting forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange of drug safety data. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
Safety Agreement. Promptly following [*] the safety departments of Amgen and Licensee shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to the Licensed Product sufficient to permit each Party, its Affiliates, permitted licensees (including permitted sublicensees) to comply with Law, including, to the extent applicable, those obligations contained in applicable Governmental Authority regulations (including those of the FDA, EMEA and MHLW). The safety data exchange procedures shall be documented in writing, and promptly updated if required by changes in Law or by agreement of the Parties.
Safety Agreement. BeiGene shall be responsible for fulfilling all pharmacovigilance requirements in the Collaboration Territory, including adverse event intake and reporting, post-marketing patient registries, and product complaint reporting, management of local labeling documents, unless, and only to the extent, otherwise required by Applicable Law, and Amgen shall provide any reasonable assistance requested by BeiGene in connection therewith, including incorporating safety monitoring and reporting for the Collaboration Territory in the overall pharmacovigilance activities; provided that with respect to XGEVA®, BeiGene shall only be responsible for the foregoing upon the date of completion of the transition services to be conducted by the Parties for XGEVA® set forth in the Transition Services Agreement. Upon the reasonable request by either Party and, if so requested, as soon as is necessary but no later than thirty (30) days after the Effective Date, the Parties shall enter into a Safety Agreement with respect to Product supplied by Amgen to BeiGene for clinical or commercial use. Any such Safety Agreement shall define the global safety database holder for each Product and define the safety governance process to be used by the Parties and be on commercially reasonable terms and sufficient to enable the Parties to fulfill their respective regulatory reporting obligations under Applicable Law.
Safety Agreement. EXHIBIT 12.8
