Regulatory Affairs Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:
Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.
Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。
Product Development Attach all requested documentation and attach additional pages as necessary. For all requirements include efforts of all Sublicensees. If not applicable, please so indicate by N/A.
Program Management 1.1.01 Implement and operate an Immunization Program as a Responsible Entity
Business Development Company Buyer is a business development company as defined in Section 202(a)(22) of the Investment Advisors Act of 1940.
Strategic Plan (1) Within ninety (90) days, the Board shall adopt, implement, and thereafter ensure Bank adherence to a written strategic plan for the Bank covering at least a three-year period. The strategic plan shall establish objectives for the Bank's overall risk profile, earnings performance, growth, balance sheet mix, off-balance sheet activities, liability structure, capital adequacy, reduction in the volume of nonperforming assets, product line development and market segments that the Bank intends to promote or develop, together with strategies to achieve those objectives and, at a minimum, include:
Strategic Planning Facilitate the effective alignment of IT requirements/ Information Resource Management (IRM) plans with strategic business plans and program initiatives. Management Improvements: Development and implementation of improved systems and business practices to optimize productivity and service delivery operations (e.g., analysis, and implementation of improvements in the flow of IT work and program processes and tool utilization, including business system analysis, identification of requirements for streamlining, re-engineering, or re-structuring internal systems/business processes for improvement, determination of IT solution alternatives, benchmarking).
Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.
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.
