REGULATORY INTERACTION AND RESPONSIBILITIES Sample Clauses

REGULATORY INTERACTION AND RESPONSIBILITIES. (a) Interaction with the FDA and any federal, state or local governmental authority in the Territory outside the United States which authority performs similar functions to the FDA (collectively, "International Regulatory Agency") involving or relating to Products may be conducted non-exclusively by USSC and SPNC agrees to fully cooperate with USSC in connection with same. SPNC shall, subject to appropriate confidentiality agreements, (a) provide USSC access to the greatest extent possible to all relevant FDA submissions (e.g. IDEs and PMAs) made by SPNC; and (b) allow USSC the right to copy and include the pertinent sections (e.g. product specifications, EMC testing, manufacturing processes and control, and biocompatability of UV laser light) of such submissions in USSC's own FDA submissions. For purpose of any filings with the FDA and any International Regulatory Agency concerning the Products, either party shall have the right to be an official company sponsor. In the event of a dispute between USSC and SPNC concerning any matter relating to such interaction with the FDA or any International Regulatory Agency solely as it relates to the Field, USSC shall have final authority to act, as USSC in its sole discretion, deems appropriate with respect to the matter in dispute. Notwithstanding the foregoing, SPNC shall have sole control of and ------------------- * This portion marked with an asterisk has been omitted pursuant to a request for confidential treatment and filed separately with the Commission. responsibility for interaction with the FDA and any International Regulatory Agency with respect to (i) SPNC qualification as a manufacturer under applicable laws and regulations of the FDA and any International Regulatory Agency; and (ii) SPNC materials used in Products regulated by such authorities. Notwithstanding the foregoing, nothing in this Agreement shall restrict (i) SPNC's right to conduct itself appropriately as determined in the exercise of SPNC's sole judgment with respect to any regulatory agency, including, without limitation, the FDA and any International Regulatory Agency, or (ii) SPNC's ability to conduct research and academic studies including, without limitation, clinical trials concerning Excimer Lasers and Probes. (b) Each party shall provide the other with a copy of any reported adverse experience involving a Product as used in the Field after a party receives the report of such occurrence whether sold by it or any third person or enti...
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Related to REGULATORY INTERACTION AND RESPONSIBILITIES

  • Position and Responsibilities During the term of Executive’s employment hereunder, Executive agrees to serve as an Executive Vice President of the Bank. Executive shall perform administrative and management services for the Bank which are customarily performed by persons in a similar executive officer capacity. During said period, Executive also agrees to serve as an officer and director of any subsidiary of the Bank or the Company, if elected.

  • Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

  • CITY’S RESPONSIBILITIES 2.1. The CITY shall designate in writing a project coordinator to act as the CITY's representative with respect to the services to be rendered under this Agreement (the "Project Coordinator"). The Project Coordinator shall have authority to transmit instructions, receive information, interpret and define the CITY's policies and decisions with respect to the CONTRACTOR's services for the Project. However, the Project Coordinator is not authorized to issue any verbal or written orders or instructions to the CONTRACTOR that would have the effect, or be interpreted to have the effect, of modifying or changing in any way whatever: (a) The scope of services to be provided and performed by the CONTRACTOR; (b) The time the CONTRACTOR is obligated to commence and complete all such services; or (c) The amount of compensation the CITY is obligated or committed to pay the CONTRACTOR. Any such modifications or changes ((a) (b) or (c)) shall only be made by or upon the authorization of the CITY’s city manager as authorized by city council in the enabling legislation or in the CITY’s procurement policies. 2.2. The Project Coordinator shall: (a) Review and make appropriate recommendations on all requests submitted by the CONTRACTOR for payment for services and work provided and performed in accordance with this Agreement; (b) Arrange for access to and make all provisions for the CONTRACTOR to enter the Project site to perform the services to be provided by the CONTRACTOR under this Agreement; and (c) Provide notice to the CONTRACTOR of any deficiencies or defects discovered by the CITY with respect to the services to be rendered by the CONTRACTOR hereunder. 2.3. The CONTRACTOR acknowledges that access to the Project Site, to be arranged by the CITY for the CONTRACTOR, may be provided during times that are not the normal business hours of the CONTRACTOR.

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

  • Role and Responsibilities During the Employment Period, the Executive shall serve as Chief Financial Officer of the Company, and shall perform such employment duties as are usual and customary for such position. The Executive shall report directly to the Chief Executive Officer of the Company (the “CEO”). At the Company’s request, the Executive shall serve the Company and/or its subsidiaries and affiliates in other capacities in addition to the foregoing, consistent with the Executive’s position hereunder. In the event that the Executive, during the Employment Period, serves in any one or more of such additional capacities, the Executive’s compensation shall not be increased beyond that specified in Section 2(b) hereof. In addition, in the event the Executive’s service in one or more of such additional capacities is terminated, the Executive’s compensation, as specified in Section 2(b) hereof, shall not be diminished or reduced in any manner as a result of such termination provided that the Executive otherwise remains employed under the terms of this Agreement.

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Roles and Responsibilities 1. The Donor States shall make funds available in support of eligible programmes proposed by the Beneficiary State and agreed on by the Financial Mechanism Committee within the priority sectors listed in Article 3.1 of Protocol 38c and the programme areas listed in the Annex to Protocol 38c. The Donor States and the Beneficiary State shall cooperate on the preparation of concept notes defining the scope and planned results for each programme. 2. The Beneficiary State shall assure the full co-financing of programmes that benefit from support from the EEA Financial Mechanism 2014-2021 in accordance with Annex B and the programme agreements. 3. The Financial Mechanism Committee shall manage the EEA Financial Mechanism 2014-2021 and take decisions on the granting of financial assistance in accordance with the Regulation. 4. The Committee shall be assisted by the Financial Mechanism Office (hereinafter referred to as the “FMO”). The FMO shall be responsible for the day-to-day operations of the EEA Financial Mechanism 2014-2021 and shall serve as a contact point.

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly XXXXX Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • Student Responsibilities The school provided Chromebook for the student is an important learning tool to be used for educational purposes. In order to use the device each day, the student must be willing to accept the following responsibilities: ● I understand that district officials have the ability to monitor my use of the device AT ALL TIMES IN AND OUT OF SCHOOL and that communications, files, internet search activities, and any other actions using the device are not considered to be private. Note: RCCSD does not have the ability to and will not remotely operate the camera on the device. However, students can cover it when not in use to ensure others are not. ● I understand that the device assigned to me is on loan from Red Clay Consolidated School District. All accounts, programs, and files are subject to inspection at any time without notice. ● I will be responsible for ALL damage or loss of the device due to NEGLECT OR ABUSE including dropping it, getting it wet, and spills of food or drink. ● I will not try to repair my Chromebook. ● At ALL times when using my Chromebook, I will follow the Acceptable Use, Internet Safety Policy, and Student Code of Conduct, and related policies adopted by the Board of Education, and abide by all local, state, and federal laws. ● I will talk with my parent/guardian about their ground rules for going online when not at school. ● I will notify the school principal and my parents of any damage to the device as soon as possible. ● I will charge the Chromebook battery each night and will bring my Chromebook to school every day or be prepared for remote learning. ● I will keep my Chromebook clean. ● I will not lend my device to anyone. This includes family members and friends. Note: I could be held responsible for any inappropriate content on the District issued Chromebook. ● I will keep all passwords assigned to me secure. ● I will only use my account credentials to sign into my Chromebook. ● I am allowed to connect to non-district printers and wireless networks at home and in public places. ● I agree that e-mail or any other computer communication should be used only for appropriate, legitimate, and responsible communication. ● I agree not to share personal information about myself (full name, address, etc.) or about my family, friends or anyone else. ● I agree not to search for, download, display, post, or distribute vulgar, offensive material or images described in applicable district policies. (See the student handbook and/or the district's Acceptable Use Agreement.) ● I agree to abide by all school rules that address electronic device procedures. ● I will return the device when requested, at the end of the school year or upon my withdrawal. ● I agree to not deface or destroy this property in any way. Inappropriate use of the machine may result in the student losing their right to use the Chromebook. ● I understand that identification labels have been placed on the Chromebook. These labels are not to be removed or modified. Additional stickers, labels, tags, or markings of any kind are NOT to be added to the machine.

  • Company’s Responsibilities Except for the items above that are the responsibility of Authority, Company will, throughout the Term of this Agreement, assume full responsibility for all nonstructural repair and maintenance of the Premises, whether such repair or maintenance be ordinary or extraordinary, and without limiting the generality hereof, Company will keep the Premises and all of Company’s trade and other fixtures, equipment, and personal property that are located on any part of the Premises or Common Use Areas open to or visible by the general public, in a clean and orderly condition and appearance; and A. Provide and maintain required fire protection and safety equipment (other than that which Authority must provide in connection with construction of Authority’s improvements) and all other equipment of every kind and nature required by any law, rule, order, ordinance, resolution or regulation of any competent authority; and B. Keep all areas of the Premises in a state of good repair subject to reasonable wear and tear; and C. Repair any damage to the surfaces of the Premises and Common Use Areas caused by use of the surfaces in excess of the approved specifications and planned use or by any oil, gasoline, grease, lubricants or other liquids or substances having a corrosive or detrimental effect thereon; and D. Be responsible for the maintenance and repair of all utility service lines, except common utility lines, if any, including but not limited to, service lines for the supply of water, gas service lines, electrical power and telephone conduits and line, retention ponds, sanitary sewers and storm sewers that are now or that may be subsequently located upon the Premises or Common Use Areas and used by Company exclusively. E. All such maintenance, repair and replacements will be of quality equal to the condition of the Premises at the commencement of the Term of this Agreement.

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