RESPONSIBILITIES AND REQUIREMENTS - CIRCA Sample Clauses

RESPONSIBILITIES AND REQUIREMENTS - CIRCA. A. Circa Responsibilities . Manufacture and test Provigil Drug Product in accordance with cGMP and the approved Provigil marketing applications. . Perform a Quality review of every lot of Provigil drug product and subsequently release or reject the lot in accordance with cGMP. . All initial and stability testing of both active and inactive components and finished dosage forms are performed in-house by the staff of the Circa Quality Control Department in accordance with approved specifications and procedures (as listed in this agreement) and/or the approved Provigil marketing applications and protocols for Provigil drug product. [LOGO OF CIRCA APPEARS HERE] . Quality Control Raw Material Report for release of each lot of modafinil drug substance tested and released for use in the manufacturing of Provigil drug product. . Quality Control Release Report for each lot of Provigil Master Blend used in the manufacturing of Provigil drug product. . Quality Control Release Report for each lot of Provigil Compression Process used in the manufacture of Provigil drug product. . Certificate of Release (to Cephalon) for each labeled and packaged lot of Provigil final drug product. . All investigations, incident reports, anomaly reports, associated with the manufacturing and testing of every lot of Provigil. The following documents shall be provided to Cephalon on a schedule mutually agreed to by Circa and Cephalon or on an as need basis: . Stability Reports . Product Quality Review Reports (Summarized annually as the "Annual Product Review)" - Summary Report - Product complaints - Summary Report - Incident reports and anomaly explanation reports - Summary Report - Production deviations - Summary Report - Out-of-specification results - Summary Report - QA product disposition - Summary Report - In-process and finished product data trends - Summary Report - Retain sample evaluation
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Related to RESPONSIBILITIES AND REQUIREMENTS - CIRCA

  • DUTIES AND RESPONSIBILITIES OF FMFS FMFS shall perform all of the customary services of a transfer agent and dividend disbursing agent, and as relevant, agent in connection with accumulation, open account or similar plans (including without limitation any periodic investment plan or periodic withdrawal program), including but not limited to:

  • Responsibilities and Duties (a) As President and Chief Executive Officer, the Executive shall serve under the board of directors of the Corporation and will perform all duties and will have all powers associated with these positions, as set forth in any job description provided to the Executive by the Corporation or as may be set forth in the bylaws of the Corporation. In addition, the Executive shall be responsible for establishing the business objectives, policies and strategic plans of the Corporation. The Executive shall report directly to the board of directors of the Corporation.

  • Duties and Responsibilities of Custodian A. Delivery of Assets ------------------ Fund will deliver or cause to be delivered to Custodian on the effective date of this Agreement, or as soon thereafter as practicable, and from time to time thereafter, all portfolio securities acquired by it and monies then owned by it (except as permitted by the Investment Company Act of 1940) or from time to time coming into its possession during the time this Agreement shall continue in effect. Custodian shall have no responsibility or liability whatsoever for or on account of securities or monies not so delivered. All securities so delivered to Custodian (other than bearer securities) shall be registered in the name of Fund or its nominee, or of a nominee of Custodian, or shall be properly endorsed and in form for transfer satisfactory to Custodian.

  • Positions, Duties and Responsibilities (A) During the Term of Agreement, the Executive shall serve as Senior Vice President and Chief Financial Officer of the Company; shall have the authority, duties and responsibilities customarily exercised by an individual serving in those positions in a corporation of the size and nature of the Company; shall perform such duties relating to the management and operations of the Company, consistent with the foregoing, as may from time to time be assigned to him by the Chief Executive Officer of the Company (the "CEO"); shall be assigned no duties or responsibilities that are materially inconsistent with, or that materially impair his ability to discharge, the foregoing duties and responsibilities; and shall report solely and directly to the CEO.

  • Position Duties and Responsibilities Place of Performance (a) During the Term of Employment, Executive shall serve as the Chief Executive Officer of the Company, together with such other position or positions consistent with Executive’s title as the Board shall specify from time to time, and shall have such duties typically associated with such title. Executive also shall serve as a member of the Company’s Board, and as an officer and/or director of any subsidiary of the Company, in each case, without additional compensation.

  • Certain Duties and Responsibilities (a) Except during the continuance of an Event of Default,

  • Facilities and Expenses The Employer will furnish the Employee with office space, equipment, supplies, computer and facsimile equipment, telephones (including cellular telephone), automobile or automobile allowance and such other facilities, support staff and personnel as the Employer deems necessary or appropriate for the performance of the Employee's duties under this Agreement. The Employer will reimburse the Employee for reasonable business expenses incurred by him on behalf of the Employer in the performance of his duties; provided, that Employee furnishes to Employer documentation of such expenses as is required by the Internal Revenue Service, as well as such other documentation as the Employer may reasonably request. In addition, the Employer shall reimburse the Employee or otherwise provide and pay for all approved professional affiliation expenses incurred by the Employee. The Employee must file authorization requests, to the extent required by the Employer's employment policies and, in all instances, expense reports with respect to such expenses in accordance with the Employer's policies.

  • Facilities and Personnel The Sub-Administrator/Accounting Agent shall provide the office facilities and personnel required by it to perform the services contemplated by this Agreement.

  • Responsibilities 1. Subject to the provisions of this Agreement, BNY shall with respect to each Specified Country select an Eligible Foreign Custodian. In connection therewith, BNY shall: (a) determine that assets of the Funds held by such Eligible Foreign Custodian will be subject to reasonable care, based on the standards applicable to custodians in the relevant market in which such Eligible Foreign Custodian operates, after considering all factors relevant to the safekeeping of such assets, including, without limitation, those contained in paragraph (c)(1) of the Rule; (b) determine that the Funds’ foreign custody arrangements with each Eligible Foreign Custodian are governed by a written contract with the Custodian which will provide reasonable care for the Funds’ assets based on the standards specified in paragraph (c)(1) of the Rule; (c) determine that each contract with an Eligible Foreign Custodian shall include the provisions specified in paragraph (c)(2)(i)(A) through (F) of the Rule or, alternatively, in lieu of any or all of such (c)(2)(i)(A) through (F) provisions, such other provisions as BNY determines will provide, in their entirety, the same or a greater level of care and protection for the assets of the Funds as such specified provisions; (d) monitor pursuant to the Monitoring System the appropriateness of maintaining the assets of the Funds with a particular Eligible Foreign Custodian pursuant to paragraph (c)(1) of the Rule and the performance of the contract governing such arrangement; and (e) advise the Funds whenever BNY determines under the Monitoring System that an arrangement (including, any material change in the contract governing such arrangement) described in preceding clause (d) no longer meets the requirements of the Rule.

  • Position, Duties and Responsibilities During the Term of Employment, Executive shall be employed and serve as the Chief Executive Officer of the Company Group (together with such other position or positions consistent with Executive’s title as the Board shall specify from time to time) and shall have such duties and responsibilities commensurate with such title, including managing the day-to-day business activities of the Company (subject to operating guidelines and budgets established by the Board from time to time). Executive also agrees to serve as an officer and/or director of any other member of the Company Group, in each case without additional compensation.

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