Regulatory and Quality Responsibilities Sample Clauses

Regulatory and Quality Responsibilities. 6.1 Genzyme shall obtain and maintain any and all regulatory and governmental permits, licenses and approvals that are necessary for Genzyme to Manufacture the Product for Semnur or its Affiliates in accordance with the terms of this Supply Agreement and Applicable Law. The Parties or their Affiliates shall enter into a Quality Agreement for the manufacture of the Product, which shall be agreed by the Parties within one-hundred twenty (120) days after the Effective Date. 6.2 Changes or Modifications in Manufacturing Activities. Genzyme shall promptly make and implement such changes as are required by Applicable Law (“Required Changes”), provided that, prior to implementation, all such Required Changes shall utilize Genzyme’s change control process. Genzyme shall inform Semnur of any estimated effect on Supply Price and other issues regarding such implementation of Required Changes if relevant. In addition, Semnur shall have the right to request changes in or modifications to the Specifications (“Voluntary Changes”). Genzyme shall review such requests for Voluntary Changes and advise Semnur if such changes are feasible. Voluntary changes require the mutual agreement of the parties. All such Voluntary Changes shall be documented in writing and shall be signed by an authorized representative of Semnur and Genzyme. Such Voluntary Changes shall utilize Genzyme’s change control process. If such Voluntary Changes result in a material change in Genzyme’s manufacturing costs or lead times or capacity, prior to implementation the Parties shall agree upon an appropriate adjustment to the Supply Price solely to reflect the actual increase in Genzyme’s manufacturing costs and compensation for Genzyme’s one-time costs necessary for such Voluntary Changes or in the delivery schedules, as the case may be, for Product(s) to be provided by Genzyme hereunder.
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Regulatory and Quality Responsibilities 

Related to Regulatory and Quality Responsibilities

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.

  • City Responsibilities 2.8.1 CITY shall make available to CONSULTANT all technical data that is in CITY'S possession, reasonably required by CONSULTANT relating to the SERVICES. 2.8.2 CITY shall provide access to and make all provisions for CONSULTANT to enter upon public and private lands, to the fullest extent permitted by law, as reasonably required for CONSULTANT to perform the SERVICES. 2.8.3 CITY shall examine all reports, correspondence, and other documents presented by CONSULTANT upon request of CITY, and render, in writing, decisions pertaining thereto within a reasonable time so as not to delay the work of CONSULTANT. 2.8.4 It is expressly understood and agreed that all work done by CONSULTANT shall be subject to inspection and acceptance by CITY and approval of SERVICES shall not forfeit the right of CITY to require correction, and nothing contained herein shall relieve CONSULTANT of the responsibility of the SERVICES required under the terms of this Contract until all SERVICES have been completed and accepted by CITY.

  • Company Responsibilities In the case of a piggyback registration of Warrant Shares, the Company shall use its best efforts to keep the Holder advised in writing as to the initiation, effectiveness and completion of such registration. At its expense the Company shall: (a) prepare and file a registration statement (and such amendments and supplements thereto) with respect to such Registrable Securities and use its best efforts to cause such registration statement to become and remain effective for a period of 180 days or until the Holder or Holders have completed the distribution described in the registration statement relating thereto, whichever first occurs; (b) furnish such number of copies of a Prospectus in conformity with the requirements of applicable law, and such other documents incident thereto as a Holder from time to time may reasonably request; and (c) use every reasonable effort to register or qualify the Registrable Securities covered by such registration statement under the state Blue Sky laws of such jurisdictions as the Company's Board of Directors may reasonably determine, and do any and all other acts and things which may be necessary under said Blue Sky laws to enable the sellers of the Registrable Securities to consummate the public sale or other disposition of the Registrable Securities owned by them in such jurisdictions, except that the Company shall not for any purpose be required to qualify to do business as a foreign corporation in any jurisdiction wherein the Registrable Securities are so qualified.

  • Mutual Responsibilities It is recognized by this Agreement to be the duty of the Company to explain fully the terms of this Agreement to all its officers, foremen and others engaged in a supervisory capacity and it is recognized to be the duty of the Union to explain fully to its members, its and their responsibilities and obligations under this Agreement.

  • 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.

  • General Responsibilities of the Parties 1. The Parties will work together in a spirit of cooperation and partnership, with the responsibilities and accountabilities set out in this Agreement, to implement the Programme Documents in full in a timely, efficient, and effective, manner. 2. The Parties agree to carry out their respective responsibilities in accordance with the provisions of this Agreement, including the Programme Documents. 3. The Parties shall keep each other informed of all relevant activities pertaining to the implementation of the Programme Documents, and shall hold consultations when either Party considers it appropriate, including any circumstance that may affect the achievement of the results of the Programme and the Programme Documents. 4. The Parties shall fulfill their commitments with the fullest regard for the terms and conditions of this Agreement and the principles of the United Nations.

  • Scope of Responsibilities The Management Committee shall have the following responsibilities: (a) Supervision and review of the work of the other ISO Committees; (b) Review and determination of appeals from actions of the other Committees, and the ability to suspend an action by another Committee pending appeal if the Management Committee determines that such suspension is warranted; (c) Development of procedures for the consideration and determination of requests for the stay of an action by another Committee; (d) Development of positions on ISO operations, policies, rules and procedures and provision of recommendations to the other Committees and the Board; (e) Preparation of the ISO capital and operating budgets for review and approval by the ISO Board; and (f) Subject to Article 19, proposing changes to the ISO OATT, the ISO Services Tariff and this Agreement, reviewing and making recommendations with respect to tariff changes proposed by the ISO Board; (g) Adoption of by-laws for the Management Committee and the review and approval of the by-laws of the other ISO Committees and amendments thereto; (h) Development of procedures and policies for all ISO Committees for the handling of confidential information; and (i) Such other responsibilities and powers conferred on it by the ISO Board. Decisions by the Management Committee may be appealed to the ISO Board by any Party.

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