Use of Immobilization Programs Provided (i) the Bank has received a certified copy of a resolution of the Board specifically approving the maintenance of Portfolio Securities in an immobilization program operated by a bank which meets the requirements of Section 26(a)(1) of the 1940 Act, and (ii) for each year following such approval the Board has reviewed and approved the arrangement and has not delivered an Officer's Certificate to the Bank indicating that the Board has withdrawn its approval, the Bank shall enter into such immobilization program with such bank acting as a subcustodian hereunder.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.
TECHNICAL SUPPORT SERVICES 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").
System and Data Access Services a.System. Subject to the terms and conditions of this Addendum and solely for the purpose of providing access to Fund Data as set forth herein, State Street hereby agrees to provide the Fund, or certain third parties approved by State Street that serve as the Fund`s investment advisors, investment managers or fund accountants (the "Fund Accountants") or as the Fund`s independent auditors (the "Auditor"), with access to State Street`s Multicurrency HORIZONR Accounting System and the other information systems described in Attachment A (collectively, the "System") on a remote basis solely on the computer hardware, system software and telecommunication links described in Attachment B (the "Designated Configuration") or on any designated substitute or back-up equipment configuration consented to in writing by State Street, such consent not to be unreasonably withheld.
Marketing Plan The Contractor shall have a Marketing Plan, that has been prior-approved by the SDOH and/or LDSS, that describes the Marketing activities the Contractor will undertake within the local district during the term of this Agreement. The Marketing Plan and all marketing activities must be consistent with the Marketing Guidelines which are set forth in Appendix D, which is hereby made a part of this Agreement as if set forth fully herein. The Marketing Plan shall be kept on file in the offices of the Contractor, LDSS, and the SDOH. The Marketing Plan may be modified by the Contractor subject to prior written approval by the SDOH and/or the LDSS. The LDSS or SDOH must take action on the changes submitted within sixty (60) calendar days of submission or the Contractor may deem the changes approved.
GENERAL SERVICE DESCRIPTION Service Provider currently provides active medical, pharmacy(Rx) and dental administration for coverages provided through Empire and Anthem (medical), Medco(Rx), MetLife(dental) and SHPS (FSA) (Empire, Anthem, Medco, MetLife and SHPS collectively, the “Vendors”) for its U.S. Active, Salaried, Eligible Employees (“Covered Employees”). Service Provider shall keep the current contracts with the Vendors and the ITT CORPORATION SALARIED MEDICAL AND DENTAL PLAN (PLAN NUMBER 502 EIN 00-0000000) and the ITT Salaried Medical Plan and Salaried Dental Plan General Plan Terms (collectively, the “Plans”) and all coverage thereunder in full force through December 31, 2011 for Service Recipient’s Covered Employees. All claims of Service Recipient’s Covered Employees made under the Plans and incurred on or prior to December 31, 2011 the (“2011 Plan Year”) will be adjudicated in accordance with the current contract and Service Provider will continue to take such actions on behalf of Service Recipient’s Covered Employees as if such employees are employees of Service Provider. All medical, dental, pharmacy and FSA claims of Service Recipient’s Covered Employees made under the Plans (the “Claims”) will be paid by the Vendors on behalf of the Service Provider. Service Recipient will pay Service Provider for coverage based on 2011 budget premium rates previously set for the calendar year 2011 and described in the “Pricing” section below. Service Recipient will pay Service Provider monthly premium payments for this service, for any full or partial months, based on actual enrollment for the months covered post-spin using enrollments as of the first (1st) calendar day of the month, commencing on the day after the Distribution Date. Service Recipient will prepare and deliver to Service Provider a monthly self xxxx containing cost breakdown by business unit and plan tier as set forth on Attachment A, within five (5) Business Days after the beginning of each calendar month. The Service Recipient will be required to pay the Service Provider the monthly premium payments within ten (10) Business Days after the beginning of each calendar month. A detailed listing of Service Recipient’s employees covered, including the Plans and enrollment tier in which they are enrolled, will be made available to Service Provider upon its reasonable request. Service Provider will retain responsibility for executing funding of Claim payments and eligibility management with Vendors through December 31, 2013. Service Provider will conduct a Headcount True-Up (as defined below) of the monthly premiums and establish an Incurred But Not Reported (“IBNR”) claims reserve for Claims incurred prior to December 31, 2011 date, but paid after that date, and conduct a reconciliation of such reserve. See “Headcount True-Up” and “IBNR Reconciliation” sections under Additional Pricing for details.
Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Program Management (WBS 1.1) All components of the Project Management Plan as implemented for the Base Contract and Options 1-4 will be reviewed and amended to reflect specific needs for Option 5 and the outcome of continuous process improvement evaluations.
