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 FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE 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 repor...
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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.
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.

Related to Safety Coordination

  • 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.

  • 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.

  • Coordinators The contractor shall assign coordinators as needed to coordinate At-Sea Monitor deployment and provide At-Sea Monitor support services. The coordinator shall be designated as key personnel under this contract (per section H.8). All coordinators are required to maintain current At-Sea Monitor Certification. Ensure that all key personnel attend any refresher trainings for At-Sea Monitors. For a specific job description see Section J, Attachment 2, Labor Category Classifications and Job Descriptions.

  • Project Managers The JBE’s project manager is: [Insert name]. The JBE may change its project manager at any time upon notice to Contractor without need for an amendment to this Agreement. Contractor’s project manager is: [Insert name]. Subject to written approval by the JBE, Contractor may change its project manager without need for an amendment to this Agreement.

  • Project Team To accomplish Owner’s objectives, Owner intends to employ a team concept in connection with the construction of the Project. The basic roles and general responsibilities of team members are set forth in general terms below but are more fully set forth in the Design Professional Contract with respect to the Design Professional, in the Program Management Agreement with any Program Manager, and in this Contract with respect to the Contractor.

  • Project Management Project Management Institute (PMI) certified project manager executing any or all of the following: • Development of Project Charter • Development of project plan and schedule • Coordination and scheduling of project activities across customer and functional areas • Consultation on operational and infrastructure requirements, standards and configurations • Facilitate project status meetings • Timely project status reporting • Address project issues with functional areas and management • Escalation of significant issues to customers and executive management • Manage project scope and deliverable requirements • Document changes to project scope and schedule • Facilitate and document project closeout

  • OVERSIGHT SERVICES Oversight services for the Fund provided by Price Associates shall include all oversight of BNY Mellon, Delegates and service providers that provide accounting, administrative, and tax support services and not specifically provided for under each Fund’s Investment Management Agreement. Exhibit B2 For Funds listed on Exhibit A2 (ETFs) Price Associates provides all accounting, administrative, tax and oversight services to the Funds listed on Exhibit A2, including the below. ACCOUNTING SERVICES Accounting Services provided by Price Associates shall include, among other things: · oversight of quality control, including processing results related to fund accounting services provided by Delegates or other third party service providers relating to pricing. Such oversight includes, but is not limited to, review of (a) NAV calculations and fund valuations, (b) securities pricing and resolution of pricing exceptions, and (c) calculation and preparation of any financial information or schedules; · end-of-day INAV oversight for ETFs that provide INAV · determining accounting and valuation policies, instructing Delegates and/or other service providers, and/or providing it with such advice that may be reasonably necessary, to properly account for all financial transactions and to maintain the Fund’s accounting procedures and records so as to ensure compliance with generally accepted accounting principles and tax practices and rules; and · calculating and authorizing expense accruals and payments; annual fund expense budgets; accrual analysis; rollforward calculations; payment of expenses; fees for payment to service providers; · facilitating on behalf of the Fund resolution and remediation of fund accounting issues escalated by Delegates and/or other service providers; · preparing daily NAV calculations, including all necessary component services such as valuation and particularly private company investment valuation, corporate actions processing, trade processing, and performing month-end and fiscal-period-end close processes; · recordkeeping as required; and · such other accounting services as agreed to by the parties not otherwise performed by Price Associates under the Investment Management Agreement. ADMINISTRATIVE SERVICES Administrative Services provided by Price Associates shall include, among other things: · ensuring maintenance for the Fund of all records that may be reasonably required in connection with the audit performed by the Fund’s independent registered public accountants, or by the Securities and Exchange Commission (“SEC”), the Internal Revenue Service (“IRS”) or such other Federal or state regulatory agencies; · cooperating with the Fund’s independent registered public accountants and taking all reasonable action in the performance of its obligations under the Agreement to assure that the necessary information is made available to such accountants for the expression of their opinion without any qualification as to the scope of their examination including, but not limited to, their opinion included in the Fund’s annual report on Form N-CSR and annual amendment to Form N-1A; · implementing and maintaining the systems, data storage and reporting necessary to perform services outlined herein; · all efforts concerning financial reporting services, including shareholder reports and financial information in regulatory filings; N-PORT and N-CEN; and other financial reporting services as necessary; · determining financial reporting policies, maintaining adequate controls over financial reporting to provide complete and accurate financial information and disclosures that are certified by officers of the Funds. Providing sub-certifications, as requested by officers of the Funds, for the adequacy of such controls and the completeness and accuracy of information included in Form N-CSR or any other form that may require certification; · periodic testing of Internal Revenue Code qualification requirements; · prepare and furnish fund performance information; · prepare and disseminate vendor survey information; · prepare and file Rule 24f-2 notices and payment; and · such other administrative services as agreed to by the parties, not otherwise performed by Price Associates under the Investment Management Agreement.

  • Project Leaders Within [**] Business Days after the Effective Date, each Party will appoint (and provide written notice to the other Party of the identity of) a senior representative having a general understanding of biopharmaceutical discovery and development issues to act as its project leader under this Agreement (each, a “Project Leader”). The Project Leaders will serve as the contact point between the Parties with respect to the Research Program, and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination of the day-to-day work and collaboration between the Parties; (b) providing single point communication for seeking consensus internally within the respective Party’s organization; and (c) raising cross-Party or cross-functional disputes in a timely manner. The Project Leaders shall conduct regular telephone conferences as deemed necessary or appropriate, to exchange informal information regarding the progress of the Research Program. Each Party may change its designated Project Leader from time to time upon prior written notice to the other Party. Each Project Leader may designate a substitute to temporarily perform the functions of that Project Leader by prior written notice to the other Party.

  • Oversight The Licensing Officer shall oversee the quality of the services provided by the Licensee and the reasonableness of the prices charged. The Licensing Officer may advise the Licensee from time to time of any source of dissatisfaction and request correction.

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