Identification of Regulated Products and Statement of Work Sample Clauses

Identification of Regulated Products and Statement of Work. Customer represents and warrants that it has specifically identified and provided to SCS in writing the identification (including, but not limited to, regulatory status and all relevant characteristics, classifications, and terms of any approval, clearance, authorization, or regulatory notification) of all Products that may constitute or contain Regulated Products. Throughout the Term, Customer will continue to identify and immediately notify SCS in writing of any Products that may constitute or contain Regulated Products not identified as of the Effective Date. Notwithstanding any other provision of this Agreement, SCS may, at its sole discretion, accept, accept with limitations, or refuse to store, warehouse, distribute, transport, or otherwise handle or address any Regulated Products (whether identified before or after the Effective Date). Customer and SCS have developed and agreed upon a written Statement of Work (“SOW”) attached to the Agreement as Exhibit A, which describes in detail SCS’ accepted functions and service locations with respect to identified Regulated Products. The SOW comprises part of the Agreement, and defines the scope of SCS’ obligation under the Agreement. The SOW does not encompass Regulated Products that are identified after the date of execution of the SOW; in the latter instance, a written amendment to the SOW will be necessary and SCS may, at its sole discretion, accept, accept with limitations, or refuse to store, warehouse, distribute, transport, or otherwise handle or address any Regulated Products identified after the Effective Date.
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Related to Identification of Regulated Products and Statement of Work

  • Customer Identification Program Notice To help the U.S. government fight the funding of terrorism and money laundering activities, U.S. Federal law requires each financial institution to obtain, verify, and record certain information that identifies each person who initially opens an account with that financial institution on or after October 1, 2003. Certain of PNC’s affiliates are financial institutions, and PNC may, as a matter of policy, request (or may have already requested) the Fund’s name, address and taxpayer identification number or other government-issued identification number, and, if such party is a natural person, that party’s date of birth. PNC may also ask (and may have already asked) for additional identifying information, and PNC may take steps (and may have already taken steps) to verify the authenticity and accuracy of these data elements.

  • Performance of Services in Accordance with Regulatory Requirements; Furnishing of Books and Records In performing the services set forth in this Agreement, the Manager:

  • Statement of Work Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract.

  • Changes in Equipment, Systems, Etc USBFS reserves the right to make changes from time to time, as it deems advisable, relating to its systems, programs, rules, operating schedules and equipment, so long as such changes do not adversely affect the services provided to the Trust under this Agreement.

  • 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.

  • Jurisdiction of Organization; Location of Chief Executive Office; Organizational Identification Number; Commercial Tort Claims (a) The name of (within the meaning of Section 9-503 of the Code) and jurisdiction of organization of each Loan Party and each of its Subsidiaries is set forth on Schedule 4.6(a) (as such Schedule may be updated from time to time to reflect changes permitted to be made under Section 6.5).

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  • Computational Materials and ABS Term Sheets (a) Not later than 10:30 a.m., New York City time, on a date no later than four business days before delivery of the Final Prospectus to the Underwriter, the Underwriter shall deliver to the Company five complete copies of all materials provided by the Underwriter to prospective investors in the Securities which constitute either (i) "Computational ------------- Materials" within the meaning of the no-action letter dated May 20, 1994 --------- issued by the Division of Corporation Finance of the Commission to Xxxxxx, Xxxxxxx Acceptance Corporation I, Xxxxxx, Peabody & Co. Incorporated, and Xxxxxx Structured Asset Corporation and the no-action letter dated May 27, 1994 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (together, the "Xxxxxx Letters") or (ii) "ABS -------------- --- Term Sheets" within the meaning of the no-action letter dated February 17, ----------- 1995 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (the "PSA Letter" and together with the ---------- Xxxxxx Letters, the "No-Action Letters"), if the filing of such materials ----------------- with the Commission is a condition of the relief granted in such letters. In the case of any such materials that constitute "Collateral Term Sheets" ---------------------- within the meaning of the PSA Letter, if such Collateral Term Sheets have not previously been delivered to the Company as contemplated by Section 10(b)(i) below, five complete copies of such Collateral Term Sheets shall be delivered by the Underwriter to the Company no later than 10:30 a.m., New York City time, on the first business day following the date on which such Collateral Term Sheets were initially provided to a potential investor. Each delivery of Computational Materials, Collateral Term Sheets and/or ABS Term Sheets to the Company pursuant to this paragraph (a) shall be effected by delivering four copies of such materials to counsel for the Company on behalf of the Company at the address specified in Section 15 hereof and one copy of such materials to the Company.

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