Risk Management and Signal Detection Activities Sample Clauses

Risk Management and Signal Detection Activities. Vertex shall be primarily responsible for all signal detection and risk management activities for Shared Products. These signal detection activities shall include, but are not limited to, proactive review and evaluation of all safety information from the Global Safety Database (including by way of example, Individual Case Safety Reports, aggregate safety information, literature reports, and non-clinical data).
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Risk Management and Signal Detection Activities. [***] shall be primarily responsible for all signal detection and risk management activities for the Shared Products. These signal detection activities shall include, but are not limited to, proactive review and evaluation of all safety information from the applicable Global Safety Database (including Individual Case Safety Reports and aggregate safety information) and other sources (including the clinical trial databases, non-clinical data, and medical or scientific literature). [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents
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Risk Management and Signal Detection Activities. The Lead Commercialization Party shall be primarily responsible for all signal detection and risk management activities for Products. These signal detection activities shall include, but are not limited to, proactive review and evaluation of all safety information from the Global Safety Database (including by way of example, Individual Case Safety Reports, aggregate safety information, literature reports, and non-clinical data). [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
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Risk Management and Signal Detection Activities. [***] shall be primarily responsible for all signal detection and risk management activities for the Shared Products. These signal detection activities shall include, but are not limited to, proactive review and evaluation of all safety information from the applicable Global Safety Database (including Individual Case Safety Reports and aggregate safety information) and other sources (including the clinical trial databases, non-clinical data, and medical or scientific literature).
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Related to Risk Management and Signal Detection Activities

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  • 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.

  • Procurement All goods, works and services required for the Project and to be financed out of the proceeds of the Financing shall be procured in accordance with the provisions of Section III of Schedule 2 to the Financing Agreement.

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  • Construction Management Landlord or its Affiliate or agent shall supervise the Work, make disbursements required to be made to the contractor, and act as a liaison between the contractor and Tenant and coordinate the relationship between the Work, the Building and the Building’s Systems. In consideration for Landlord’s construction supervision services, Tenant shall pay to Landlord a construction supervision fee equal to three percent (3%) of Tenant’s Costs specified in Section 7.

  • Operation of the Business Between the date of this Agreement and the Closing, Seller shall:

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