Safety Coordination Sample Clauses

Safety Coordination. Promptly following Sobi’s exercise of its Opt-In Right for a Product, the Parties shall enter into a safety data exchange agreement with respect to such Product that shall apply to the MAH Transfer Period for EMA (as it may be amended from time to time, the “Safety Data Exchange Agreement”). The Parties shall prepare an amendment to the initial Safety Data Exchange Agreement to be effective upon the completion of the MAH transfer to Sobi to reflect Sobi’s role as the MAH. Promptly after execution of the initial Safety Data Exchange Agreement, the Parties shall negotiate in good faith such amendment with the intention to execute such amendment no later than six months after the exercise of such Opt-In Right. If there is any conflict between the provisions of a Safety Data Exchange Agreement for a given Product and this Section 4.6, the provisions of such Safety Data Exchange Agreement shall prevail. The Parties agree to share a single Core Data Sheet. Biogen Idec shall be responsible, either itself or through a Contract Research Organization (“CRO”), for the provision of a centralized pharmacovigilance database for all Products (the “Global Safety Database”). For each Product in respect of which Sobi has exercised its Opt-In Right, Biogen Idec (or its appointed CRO) shall promptly provide to Sobi all information in the Global Safety Database necessary for Sobi to comply with its obligations to report Safety Events (to be defined in the applicable Safety Data Exchange Agreement), including read only electronic access at all times. Each Party shall, and shall ensure that its Affiliates and Sublicensees shall, promptly provide to such CRO (or if Biogen Idec elects to maintain the Global Safety Database itself, Biogen Idec), for inclusion in the Global Safety Database all Safety Event information with respect to such Product. Each Selling Party shall comply with all applicable law with respect to the reporting of Safety Events in its Territory where the Product is undergoing Post Opt-In Development or is being Commercialized. The Party sponsoring any clinical trial with respect to a Product shall be legally responsible for reporting any Safety Events with respect to such Product to the relevant Regulatory Authorities and other government authorities in accordance with regulatory requirements, and the Party Commercializing the Product in a country shall be legally responsible for reporting any Safety Events with respect to such Product to the relevant Regulatory...
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Safety Coordination. With respect to the Product, the Parties shall, as soon as practical after the inclusion of such Product in the Collaboration, contract with a Contract Research Organization (“CRO”) to provide a centralized pharmacovigilence database (the “Safety Database”) for such Product, pursuant to which, among other things, the CRO shall promptly provide to each Party all information in the Safety Database necessary for such Party to comply with its obligations to report adverse events (“AEs”). Each Party shall, and shall ensure that its Affiliates and sublicensees, shall promptly provide to the CRO, for inclusion in the Safety Database all AE information with respect to such Product. Each Party shall comply with all applicable law with respect to the reporting of AEs. The Party sponsoring any clinical trial with respect to a Product shall be responsible for reporting any AEs with respect to such Product to the relevant Regulatory Authorities and other government authorities, and the Party Commercializing the Product in a country shall be responsible for reporting any AEs with respect to such Product to the relevant Regulatory Authorities and other government authorities in such country. Notwithstanding the foregoing, the procedures set forth in this Section 4.5 shall not be construed as restricting either Party’s ability to take any action that it deems to be appropriate or required of it under applicable law.
Sample 1
Safety Coordination. Omnitrans and SCRRA shall comply with all applicable safety laws, standards, codes, rules, and regulations. Omnitrans and SCRRA shall cooperate and coordinate with Tenant Railroads, the Dispatch Contractor, the MOW Contractor, the Right of Way Contractor and any Third-Party Contractors on safety matters. Omnitrans and SCRRA shall promptly comply with any specific safety instructions or directions given by any duly authorized regulatory agency.
Sample 1

Related to Safety Coordination

  • Project Coordination The Engineer shall coordinate all subconsultant activity to include quality and consistency of deliverables and administration of the invoices and monthly progress reports. The Engineer shall coordinate with necessary local entities.

  • Care Coordination The Parties’ subcontract shall require that the Enrollee’s CP Care Coordinator provide ongoing care coordination support to the Enrollee in coordination with the Enrollee’s PCP and other providers as set forth in Section 2.6.

  • Utility Coordination Identify all potential utility conflicts and provide preliminary office check plans showing the problem locations, posted to the City’s FTP site. Plans will clearly identify specific utility company facilities by color and by name (i.e. not just “gas” or “fiber optic”). ENGINEER shall include a conflict list for each utility, also posted to the FTP site. ENGINEER shall meet with utility company representatives to review plans and utility verification forms (Attachment No. 3 to Exhibit “A”) at each milestone date and as directed by the CITY and as determined necessary by the ENGINEER. This in- formation will be compiled into a summary report (Attachment No. 4 to Exhibit “A” also available on the City’s FTP site) maintained and updated by ENGINEER as necessary to present a cohesive and reflective status of utilities, and provided to the City as necessary. ENGINEER shall maintain involvement with utility companies until all conflicts have been resolved (not just identified). When appropriate, the City Engineer will approve the identification on plans of conflicts to be resolved during construction. ENGINEER shall meet with involved utility company/ies and project contractor to resolve any conflicts with utilities that occur during construction.

  • Project Management and Coordination The Engineer shall coordinate all subconsultant activity to include quality of and consistency of work and administration of the invoices and monthly progress reports. The Engineer shall coordinate with necessary local entities.

  • Coordination The Parties shall confer regularly to coordinate the planning, scheduling and performance of preventive and corrective maintenance on the Large Generating Facility and the Interconnection Facilities.

  • Cooperation and Coordination The Parties acknowledge and agree that it is their mutual objective and intent to minimize, to the extent feasible and legal, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use all commercially reasonable efforts to cooperate and coordinate with each other to achieve such objective.

  • Project Coordinator Within 14 days of the effective date of this Consent Agreement, DTSC and Respondent shall each designate a Project Coordinator and shall notify each other in writing of the Project Coordinator selected. Each Project Coordinator shall be responsible for overseeing the implementation of this Consent Agreement and for designating a person to act in his/her absence. All communications between Respondent and DTSC, and all documents, report approvals, and other correspondence concerning the activities performed pursuant to this Consent Agreement shall be directed through the Project Coordinators. Each party may change its Project Coordinator with at least seven days prior written notice.

  • Order Coordination and Order Coordination-Time Specific 2.1.9.1 “Order Coordination” (OC) allows BellSouth and Lightyear to coordinate the installation of the SL2 Loops, Unbundled Digital Loops (UDL) and other Loops where OC may be purchased as an option, to Lightyear’s facilities to limit end user service outage. OC is available when the Loop is provisioned over an existing circuit that is currently providing service to the end user. OC for physical conversions will be scheduled at BellSouth’s discretion during normal working hours on the committed due date. OC shall be provided in accordance with the chart set forth below. 2.1.9.2 “Order Coordination – Time Specific” (OC-TS) allows Lightyear to order a specific time for OC to take place. BellSouth will make every effort to accommodate Lightyear’s specific conversion time request. However, BellSouth reserves the right to negotiate with Lightyear a conversion time based on load and appointment control when necessary. This OC-TS is a chargeable option for all Loops except Unbundled Copper Loops (UCL) and Universal Digital Channel (UDC), and is billed in addition to the OC charge. Lightyear may specify a time between 9:00 a.m. and 4:00 p.m. (location time) Monday through Friday (excluding holidays). If Lightyear specifies a time outside this window, or selects a time or quantity of Loops that requires BellSouth technicians to work outside normal work hours, overtime charges will apply in addition to the OC and OC-TS charges. Overtime charges will be applied based on the amount of overtime worked and in accordance with the rates established in the Access Services Tariff, Section E13.2, for each state. The OC-TS charges for an order due on the same day at the same location will be applied on a per Local Service Request (LSR) basis.

  • Scheduling Coordinator Buyer shall act as the Scheduling Coordinator for the Project. In that regard, Buyer and Seller shall agree to the following:

  • Service Coordinators Each Party has designated an employee or title as the key contact for the day-to-day implementation or monitoring of each Service as specified in the applicable Transition Service Schedule (each, a “Service Coordinator”). The Parties shall direct communications relating to specific Services to the applicable Service Coordinators. The Service Coordinators shall report to the Transition Committee from time to time, as directed by the members of the Transition Committee designated by the applicable Party.

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